Job Description
Date
02/2021
Location
1200 Airport Road, North Brunswick NJ
Title
Associate, Quality Control Documentation
Department
Quality Control
Reports to
Manager, QC Documentation
FLSA (Exempt or Non-Exempt
Non-Exempt
Role Overview
The Associate, QC Documentation 1 primary responsibility is to coordinate within QC and with other departments to create, revise and manage technical and regulatory documents for raw materials efficiently and accurately. This position provides project/study and investigation support through review and technical writing of GMP documents (e.g., study specific protocols or validation reports), SOPs and other documents associated within QC area of responsibility. Additionally, the Associate will ensure the quality of laboratory data and reports and provide document coordination.
Areas of Responsibility
Writes stability protocols / reports for samples Reviews various microbiology related documents like notebooks, receiving logs, calibration reports, and calibration books Prepares & reviews microbial CoA’s and reportsPerforms microbial testing when required, instrument, calibrations, and swab samplingsMaintains & keeps records as per GMP Writes and reviews /updates QC SOPs and STPsComplies with all regulatory/ in-house requirements (may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP,GLP, documentation) when performing the assigned activity. Performs Quality Control (QC) checks on supplier’s CoAs vs RMS requirements, third-party testing data and test required/ results for conformance to both normative and client specifications where applicable.Communicates with QA regarding third-party testing reports availabilities and discrepanciesInterpret and communicate test results intra department including any associated normative in RMS/CoA generation.Reviews, verifies and approves of Internal QC Instruments calibration / qualification.Engages in customer service interactions by electronic, telephone, and/or direct in-person correspondence pertaining to Calibrations, Annual PM and repairsAct as liaison between Research and Development and the Quality Control Lab to ensure specifications and test methods are completed fully and according to priorityGRN updates on Syspro related to PO placed for QCMust be able to work extended hours as needed and occasional weekends.Other Duties as AssignedOther Responsibilities Including Safety:
Works in a safe and responsible manner to create an injury-free and incident-free workplace.Complies with all job-related safety and other training requirements.Keeps management informed of area activities and of any significant problems.Requirements
Education & Qualification:
BS /MS in Chemistry or related scientific disciplines2+ years of technical writingMinimum of 3+ years QC lab work experience with industry experience in dietary supplements, food or OTC manufacturing.Certifications, Licenses, Credentials:
N/ASkills & Ability
Demonstrate strong command of English written and spoken language skillsPossesses advanced MS Office software and have excellent typing skillsAble to communicate corporate compliance issues to department heads Able to maintain professional and positive attitudeAble to manage multiple tasks effectively & efficientlyPossess high-level of ethics and integrityMust be able to keep information confidentialPhysical Requirements (lifting, etc.):
Ability to navigate office, lab, and/or plant floor working environments. Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances and leaning over equipment as well as kneeling on the floor to clean under the equipment.Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators.On occasion may need to lift up to 35 lbsWork Environment (Office, Warehouse, temperature extremes, etc.):
Work is regularly performed in the office where temperatures are controlled, noise level is usually moderate, and area is without unpleasant or hazardous conditions.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
USPL is proud to be an Equal Opportunity Employer.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.
Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment.
Read LessJob Description
Date
06/2025
Location
1300 Airport Road, North Brunswick NJ 08902
Title
Associate, In-Process Quality Assurance MFG/PKG
Department
Quality Assurance Operation Support
Reports to
Quality Assurance Manager/ VP of QA
FLSA (Exempt or Non-Exempt
Non-Exempt
Role Overview
The IPQA performs line inspection as part of the cGMP, SOPs, and policy compliance requirements as per CFR part 111. Performs In-process quality testing in manufacturing and/or packaging areas according to prescribed timelines and accurately captures test results in batch records. The Inspector performs calibrations & measurements on raw materials, bulk products, finished products and packaging components as required in batch records and SOP’s. This position reports to the QA Manager and is a key member of the Quality Assurance group. The IPQA Associate is a highly organized self-starter who can work independently, demonstrates a positive attitude, and a bias for action.
Areas of Responsibility
IPQA – Level 1: To support In-process quality assurance activities by performing routine checks and verifications during manufacturing and/or packaging of nutraceutical products. This role ensures that all processes comply with applicable GMP, SOPs, and regulatory requirements.
Key Responsibilities:
???? Manufacturing Support
Perform line clearance before starting blending, granulation, compression, encapsulation, coating processes.Perform In-process checks:Blend uniformity samplingTablet/capsule weight variationHardness, friability, and disintegration tests etc as applicableVerify equipment cleaning and area hygiene as per SOP.Collect and label In-process and stability samples under supervision.???? Packaging Support
Ensure line clearance before packaging activities.Perform In-process checks:Batch number and expiry date printingLabel application and carton sealingPrimary and secondary packaging integrity etc as applicableAssist in reconciliation of packaging materials (e.g., printed cartons, leaflets, labels).???? Documentation
Record observations in IPQA checklists, logbooks, and batch records.Maintain GMP documentation in real-time (legible and error-free).Escalate any deviation or abnormality immediately to the QA Executive/Supervisor.???? Compliance & Safety
Adhere to company GMP, SOP, and Hygiene policies.Use PPE appropriately.Support during internal/external audits by providing necessary records.Cleans up work following the completion of a shift.Meets all safety expectations and follows all safety practices.Works extended hours and occasional weekend overtime.Other duties as assignedOther Responsibilities Including Safety:IPQA – Level 2: To independently perform and document In-process quality assurance activities at all critical stages of manufacturing and packaging of nutraceutical products, ensuring compliance with GMP, SOPs, and regulatory requirements.
Key Responsibilities:
???? Manufacturing Stage (Granulation, Blending, Compression, Encapsulation, Coating )
Carry out and document line clearance activities before starting each manufacturing batch.Conduct in-process checks independently:Blend uniformity samplingTablet/capsule weight variationHardness, friability, thickness, and disintegrationIn-process controls as per BMR specificationsVerify equipment cleanliness status, calibration, and logbook entries.Monitor and record environmental conditions in production areas (temperature, RH, differential pressure).???? Packaging Stage
Conduct line clearance for primary and secondary packaging (bottles, strips, blister, cartons).Perform and document:Batch coding verification (batch no., Mfg/Exp date)Packaging material correctness (labels, leaflets, cartons)Sealing integrity checks (blisters, induction seals)Online rejection bin and reconciliation checksEnsure correct usage of approved packaging materials with status labels.???? Documentation & Compliance
Fill Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) in real-time.Record IPQA observations and results as per SOPs ( legible and error free).Initiate and report deviations, OOS/OOT, and non-conformities to QA Supervisor/ Manager.Support CAPA implementation and change controls.???? General QA Duties
Ensure compliance with GMP, GLP, and data integrity principles.Follow gowning protocols, hygiene, and safety measures in production areas.Assist during internal audits and regulatory inspections by providing accurate documentation and data.Cleans up work following the completion of a shift.Meets all safety expectations and follows all safety practices.Works extended hours and occasional weekend overtime.Other duties as assignedOther Responsibilities Including Safety:IPQA – Level 3: To lead and monitor In-process QA activities during nutraceutical manufacturing and packaging operations. Ensure compliance with GMP, regulatory standards, and internal SOPs by supervising IPQA teams, reviewing records, and addressing quality deviations.
Key Responsibilities:
????IPQA Oversight – Manufacturing & Packaging
Supervise and verify line clearance activities across all manufacturing and packaging areas.Ensure compliance with critical process parameters (CPPs) and critical quality attributes (CQAs).Review and approval:In-process checks: weight variation, hardness, friability, disintegration etc as applicableEnvironmental monitoring recordsEquipment and area cleaning recordsCoordinate and monitor sampling activities for In-process, finished products and stability studies.???? Review and Verification
Review and verify completed Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).Cross-check reconciliation of raw materials and printed packaging materials.Verify proper use of status labels (approved/rejected/quarantine).???? Deviation & CAPA Management
Investigate and document process deviations, non-conformances, and OOS/OOT incidents.Lead root cause analysis (RCA) and implement Corrective and Preventive Actions (CAPA).Coordinate with cross-functional teams (Production, QC, Regulatory Affairs) to ensure closure of quality events.???? Audit & Compliance
Ensure readiness for internal, external, and regulatory audits (FSSAI, WHO-GMP, USFDA, etc.).Conduct routine GMP audits, spot checks, and area inspections.Train shop-floor personnel on data integrity, documentation practices, hygiene, and gowning protocols.???? Team Coordination
Guide and mentor IPQA Level 1 and Level 2 personnel.Allocate daily QA responsibilities and monitor adherence to QA procedures.Conduct on-the-job training for new team membersCleans up work following the completion of a shift.Meets all safety expectations and follows all safety practices.Works extended hours and occasional weekend overtime.Other duties as assignedOther Responsibilities Including Safety:Meets all safety expectations and follows all safety practices.Works extended hours and occasional weekend overtime.Other duties as assignedOther Responsibilities Including Safety:N/AOther Responsibilities Including Safety:
Works in a safe and responsible manner to create an injury-free and incident-free workplace.Complies with all job-related safety and other training requirements.Keeps management informed of area activities and of any significant problems.Requirements
Education & Qualification:
IPQA – Level 1:
0–1 year (Freshers with training or internship in QA preferred)Or equivalent combination of education and experience.High School diploma is required; BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus.IPQA – Level 2:
Minimum of 3+ years of experience in a QA Inspector within a nutritional’s supplements, food, consumer products or pharmaceutical company. Or equivalent combination of education and experience.BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus.IPQA – Level 3:
3–5 years in IPQA or related QA roles in nutraceuticals, pharmaceuticals, or food manufacturing. Or equivalent combination of education and experience.BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus.Certifications, Licenses, Credentials:
N/ASkills & Ability
IPQA – Level 1:
Basic understanding of GMP, nutraceutical processes, and QA principles.Good observation and attention to detail.Willingness to work in production areas (shifts, growing zones).Ability to follow instructions and standard procedures accurately.Basic proficiency in English and documentation practices.IPQA – Level 2:
Strong knowledge of IPQA functions, SOPs, and process flow in nutraceuticals.Understanding of basic analytical parameters (weight variation, friability, etc.).Good documentation and observational skills.Proficient in using basic lab and QA tools (weighing balances, disintegration testers).Familiar with regulatory guidelines (FSSAI, WHO-GMP, USFDA, HACCP).IPQA – Level 3:
In-depth understanding of nutraceutical manufacturing processes and regulatory compliance.Proficient in QA documentation, process audits, and deviation handling.Strong analytical and decision-making skills.Familiar with QMS tools, GMP documentation, and data integrity principles.Working knowledge of SOP writing, change control, and risk assessment.Physical Requirements (lifting, etc.):
Ability to lift up to 35 lbs.; occasionally lift and move up to 50 pounds.Must stand and walk on production floor a minimum of 6 hours per shiftUses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances.Occasionally works from a rolling ladder or step stool. Must be able to wear all PPE including lab coat, face mask, booties, gloves, safety glasses.Work Environment (Office, Warehouse, temperature extremes, etc.):
Work is regularly performed inside a manufacturing and packaging environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
USPL is proud to be an Equal Opportunity Employer.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.
Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment.
shift schedule
1st shift: 7:00 AM - 3:30 PM,2nd shift: 3:15 PM - 11:45 PM and 3rd shift: 11:00 PM - 7:30 AM
Read LessJob Description
Date
02/24/2024
Location
1300 Airport Rd, North Brunswick NJ
Title
Supervisor, Maintenance Packaging
Department
Engineering / Maintenance
Reports to
Plant Engineer
FLSA (Exempt or Non-Exempt)
Exempt
Role Overview
The Packaging Maintenance Supervisor leads the packaging maintenance team in the maintenance, repair, and upgrading of all packaging systems including changes and improvements in maintenance and repair methods. Will work closely with Engineering and packaging teams on scheduling major repairs, new equipment installations and support qualification of packaging equipment. Help in preparing maintenance checklist and procedures for equipment used in the packaging area.
Areas of Responsibility
Provides day-to-day direction, supervision, and coaching to the team to meet site objectives and goals. Monitors progress and directs activities.Responsible for the productivity of personnel regarding timeliness in diagnosing and completing necessary maintenance and repairs.Ensures a well-functioning preventative maintenance program.Reviews site performance measures and key results and takes appropriate actions.Maintains good labor relations, morale, and discipline in shop; Initiates corrective actions when required.Ensures personnel follow all GMP and safety policies.Works with accountability group(s) to meet KPI’s.Maintains, repairs, adjusts, all packaging lines and mechanical systems as required to meet packaging needs.Troubleshoots and repairs all related packaging machine problems with competent speed and accuracy.Reads and interprets blueprints, sketches, schematic drawings, and manufacturer’s instructions.Determines materials and supplies needed to accomplish maintenance and repair.Instructs other personnel in the proper performance of their duties as may be required.Responsible for the Packaging Technicians work schedule; to ensure adequate production coverage.Ensure adequate spare part inventory to minimize downtime during breakdown.Other duties as assigned.Other Responsibilities Including Safety:
Works in a safe and responsible manner to create an injury-free and incident-free workplace.Complies with all job-related safety and other training requirements.Keeps management informed of area activities and of any significant problems.Requirements
Education & Qualification:
Minimum of 3 years maintenance experience required; 5 years of maintenance experience is preferred.Minimum of 2 years’ experience in a packaging operationMinimum of 3 years supervisory experienceOr equivalent combination of education and experienceAutomated equipment controls experienceKnowledge of preventive and predictive maintenance programs and standardsDemonstrated strategic thinking skill; able to develop and execute long term plans.Strong computer skills, including Microsoft Office, SAP, and Outlook required.Must also understand process control software and reporting functions.Must establish relationships and address conflict through appropriate resolution skills and techniques.Must consistently maintain and demonstrate a high regard for personal safety, for the safety of company assets, and employees.May lift weights up to 50 pounds unassisted.Must be willing to work overtime, nights, weekends, and holidays as needed.Must be able to perform all functions in accordance with established safety procedures.Must have working knowledge of:Pneumatic systemsConveyor beltsEquipment controls logicPower transmission devices (V-belt, sheaves, chain and sprockets, bearings)High speed check-weighers and metal detectors including gravity.Machine lubrication and knowledge of different types of lubricantsBasic machine elements such as glue pumps, gear reducers, clutches, brakes, and valvesStrong knowledge of Food Safety, Regulatory, and Good Manufacturing Practices is preferred.A degree in mechanical engineering from an accredited college or university OR equivalent related experience required.Certifications, Licenses, Credentials:
N/ASkills & Ability
Electrical skills including the understanding of 480-volt equipment and troubleshooting (controls voltage, DC applications)Must establish relationships and address conflict through appropriate resolution skills and techniques.Must have ability to diagnose and correct operating issues with packaging machines and allied equipment.Must be able to lead assigned teams in a continuous improvement environment.Must demonstrate trouble-shooting skills, strong computer skills, as well as strong verbal and written communication abilities.SAP/Syspro experience is preferred.Project management experience: major repairs experience is preferred.Physical Requirement
Ability to navigate office, lab, and/or plant floor working environments. Standard office environment without unpleasant or hazardous conditions. Physical demands involved in office work such as the ability to talk, hear, use hands to handle and feel; work on a computer up to 7 hours a day; close vision required for computer usage.Must have the ability to wear applicable personal protective equipment utilized at this site, including safety glasses/goggles, hairnets, lab coats and safety shoes.Work Environment (Office, Warehouse, temperature extremes, etc.):
Exposed to lab and/or plant floor working environments. Standard office environment without unpleasant or hazardous conditionsTemperature controlled for heat and air conditioning.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
USPL is proud to be an Equal Opportunity Employer.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.
Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment.
Read LessJob Description
Date
05/2021
Location
1300 Airport Road, North Brunswick NJ
Title
Assistant, Maintenance
Department
Maintenance and Engineering
Reports to
Manager, Engineering.
FLSA (Exempt or Non-Exempt
Exempt
Role Overview
The Maintenance Assistant will be responsible to assist the Maintenance and engineering team with assigned tasks such as machine disassembly and cleaning, dust collector monitoring and disposal of accumulated dust, inventory of spare parts, assist with machine repairs and new equipment installation when required, assist with facilities repairs when required, escorting vendors working on facilities and engineering related work among other day to day activities
Areas of Responsibility
Follows oral and written instructions.Washing/Cleaning equipment and parts in production areas.Responsible for assisting with all production related electrical and mechanical installation, and preventive maintenance.Completes and understand training requirements as identified by the department. This includes all SOPs referring to job related task, documentation procedures, safety and cGMP’s.Completes assignments in a timely manner.Monitors equipment within the facility for possible repairs and upkeep.Housekeeping of the maintenance ownership sections, and other areas as required to support the facilities and engineering team.Reports any problems identified during the daily work routine back to the Maintenance Manager/supervisor or leadership team for further action.Follows Environmental Health and Safety (EHS) policies and procedures, adhering to safety codes and guidelines for yourself and others throughout the plant.Disassembles and clean equipment properly in preparation for changeover and new batch.Assist in maintaining preventative maintenance supplies (oil, grease etc.) by checking inventory.Follows daily logs on preventative maintenance.Reads and interpret equipment manuals. Uses a variety of hand and power tools, electric meters, and material handling equipment in performing duties. Ensures full compliance with Company policies, procedures, GMP’s, Ethical Business Practice, and SOPs at all times. Responds to emergency calls including snow removal, utility failures, and disaster response.Undertakes and complete assigned tasks in a timely manner and reports the same to team leaders.Maintains proper gowning and hygiene to ensure personal safety and integrity of the product as per company policies.Works extended hours and occasional weekend overtime as may be required Must be able to provide emergency/unscheduled assistance for repairs of production equipment during production. Participates in regulatory inspections from various organization such as FDA, Environmental Protection and Fire Department.Other duties as assigned.Other Responsibilities Including Safety:
Works in a safe and responsible manner to create an injury-free and incident-free workplace.Complies with all job-related safety and other training requirements.Keeps management informed of area activities and of any significant problems.Requirements
Education & Qualification:
High school graduate or GED equivalent 1+ years of industrial experience preferably in maintenance department.Certifications, Licenses, Credentials:
N/ASkills & Ability
Demonstrates ability to work in a team and assist others.Able to follow written instructions precisely and perform basic math calculations as required.Understands and is knowledgeable of cGMP, OSHA standards etc.Mechanically inclined to understand inner workings of equipment.Demonstrates the ability to read and write basic English to be able to understand the industry regulated instruction sheets.Must have attention to detail.Physical Requirements (lifting, etc.):
Ability to lift up to 50 lbs.; occasionally lift and move up to 75 pounds.Must stand and walk on production floor a minimum of 6 hours per shiftUses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances.Occasionally works from a rolling ladder or step stool, must be to lean over equipment as well as kneeling on the floor to clean under the equipment.Must be able wear all PPE including lab coat, face mask, booties, gloves, safety glasses/goggles and respirators.Work Environment (Office, Warehouse, temperature extremes, etc.):
Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employee can be exposed daily to chemicals and cleaning agents.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
USPL is proud to be an Equal Opportunity Employer.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.
Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment.
Job Description
Date
02/2024
Location
1300 Airport Road, North Brunswick NJ
Title
Lead, Quality Control Chemist
Department
Quality Control
Reports to
Manager, Quality Control Laboratory
FLSA (Exempt or Non-Exempt
Exempt
Role Overview
The Lead, QC Chemist performs specific routine analysis of samples of raw materials, in process, and finished products according to established (official and/or in-house) test procedures. Testing assesses the strength, identify, purity of the test samples and/or raw materials. The Chemist prepares reagents, standards, and solutions and may monitor and verify quality in accordance with statistical process and other control procedures. The Chemist maintains & organizes testing’s and compliance while working in a fast-paced environment with changing priorities.
Areas of Responsibility
Performs assigned sampling, physical, chemical tests and assay on raw materials, active dietary ingredients, in-process, finished, and stability products in an FDA regulated lab environment. Uses a variety of wet chemicals, physical and instrumental techniques as well as routine QC instruments HPLC, GC, IR, Auto Titrator, Bulk Density, UV Spectrophotometer, Dissolution, Karl Fisher (KF), Potentiometer. Troubleshoots HPLC, GC, QC instruments for specific tests in order to assist in determining the root cause of aberrant results and help in performing Lab investigations / OOS.Evaluates daily raw data sheets for product samples and release, if needed.Coordinates annual review of STPS / SOPS as per USPL procedures.Prepare new methods and test procedures for new or existing raw materials and finished products.Ensures compliance with company and customer specifications as well as federal, state and local regulatory requirements.Perform floor supervision of QC Chemists for routine testing, if required.Prepares and reviews QC related documents during and finishing of testing of sample. Submit all testing related documents like data sheets, chromatograms, spectras, instruments print outs in timely manner to Qc Documentation department to release the batch of raw material / finished product.Prepares and/or Reviews Test Procedures, SOP's and Protocols as assigned.Performs maintenance and calibrations of laboratory instruments /equipment, if required to help in-house calibrations.Assures GMP compliance according to FDA CFR Part 111 and USPL SOPs / guidelines.Complies with all regulatory/ in-house requirements (may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP, GLP, documentation) when performing the assigned activity.Trains new QC Chemists to perform instrumental testing.Must be able to work extended hours as needed and occasional weekends.Other duties and responsibilities as assigned by QC in-charge / management.Other Responsibilities Including Safety:
Works in a safe and responsible manner to create an injury-free and incident-free workplace.Complies with all job-related safety and other training requirements.Keeps management informed of area activities and of any significant problems.Requirements
Education & Qualification:
BS/MS in Chemistry or related scientific disciplines.Five (5) years of basic chemistry techniques (can be academic) is a plus.Minimum of 5 years QC lab work experience in handling HPLC, GC, KF, Dissolution, DT and other sophisticated lab instruments in dietary supplements, food or OTC / Pharmaceutical manufacturing industry.Certifications, Licenses, Credentials:
N/ASkills & Ability
Ability to maintain integrity and honesty at all times and to communicate with transparency. Ability to work independently or as part of a team. Solid understanding of cGMP’s and GLP and is familiar with 21 CFR Part 11.Strong working knowledge of Microsoft Word, Excel.Good documentation practices and able to write simple, clear reports.Meets commitments on time and practices time-management skills.Seeks to identify continuous improvement needs.Experience with Shimadzu LC2010, Nexera, GC2010, Thermo ICP-MS, Labsolution and Waters Empower Lab Software a plus.Physical Requirements (lifting, etc.):
Ability to navigate office, lab, and/or plant floor working environments. Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances and leaning over equipment as well as kneeling on the floor to clean under the equipment.Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators.On occasion may need to lift up to 20lbsWork Environment (Office, Warehouse, temperature extremes, etc.):
Work is regularly performed inside a laboratory environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.May execute up to 20% of their work at the bench level either standing or sitting on a stool. Work performed in a standard office environment is without unpleasant or hazardous conditions.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
USPL is proud to be an Equal Opportunity Employer.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.
Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment.
Job Description
Date
05/2025
Location
1200 Airport Road, North Brunswick NJ
Title
Technician, QC Analytical
Department
Quality Control
Reports to
Manager, Chemistry Laboratory
FLSA (Exempt or Non-Exempt
Non-Exempt
Role Overview
We are seeking a detail-oriented and skilled Laboratory Technician to join our Chemistry Lab division. The successful candidate will support physical and chemical testing of raw materials, R&D, Method development / Stability and finished products using various analytical instruments / Equipment’s and techniques to ensure compliance with internal specifications.
Areas of Responsibility
Prepare samples, Mobile Phase, Buffer solution, Dissolution Media, Sample digestion etc. for analysis according to standard operating procedures (SOPs) or as per suitable method provided by senior management.Perform chemical analyses using techniques such as UV-Vis, Dissolution, FTIR, titration, Microwave Digestion system, TOC water sample and physical testing using apparatus and equipment’s’ such as Disintegration, Bulk Density, Tap Density, Loss on Drying, Karl Fisher, etc.Accurately record, and report test results in compliance with GLP/GMP standards.Calibrate, maintain, and troubleshoot laboratory instruments and equipment. Example-pH meter, Weighing Balance, etc.Maintain a clean, organized, and safe work environment.Assist in the development and validation of analytical methods under supervision.Document laboratory activities and results in lab notebooks, Raw Datasheets, and on computer system with validated excel.Dispose of chemical waste properly and follow all environmental, health, and safety (EHS) protocols.Participate in quality audits and continuous improvement initiatives.Must be able to work extended hours as needed and occasional weekends.Other duties and responsibilities as assigned.Other Responsibilities Including Safety:
Works in a safe and responsible manner to create an injury-free and incident-free workplace.Complies with all job-related safety and other training requirements.Keeps management informed of area activities and of any significant problems.Requirements
Education & Qualification:
Associate's or Bachelor's degree in Chemistry, Biochemistry, or related scientific field.0–3 years of hands-on experience in an analytical chemistry lab (academic or industrial).Strong understanding of laboratory safety and quality standards (e.g., GMP, GLP, ISO).Good problem-solving and organizational skills with attention to detail.Ability to work independently and collaboratively within a team.Certifications, Licenses, Credentials:
N/ASkills & Ability
Ability to maintain integrity and honesty at all times and to communicate with transparency. Ability to work independently or as part of a team. Solid understanding of cGMP’s and GLP and is familiar with 21 CFR Part 11Strong working knowledge of Microsoft Word, Excel.Good documentation practices and able to write simple, clear reports Meets commitments on time and practices time-management skillsSeeks to identify continuous improvement needsExperience with Shimadzu LC2010, Nexera, GC2010, Thermo ICP-MS, Labsolution and Waters Empower Lab Software a plus.Physical Requirements (lifting, etc.):
May execute 90%-100% of their work at the bench level either standing or sitting on a stool. Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances and leaning over equipment as well as kneeling on the floor to clean under the equipment.Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators.On occasion may need to lift up to 35 lbs.Ability to navigate office, lab, and/or plant floor working environments.Work Environment (Office, Warehouse, temperature extremes, etc.):
Approximately 80% of work performed in a laboratory environment which may have unpleasant odors or hazardous conditions. Temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
USPL is proud to be an Equal Opportunity Employer.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.
Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment.
Job Description
Date
11/2020
Location
1300 Airport Road, North Brunswick NJ
Title
Production Operator
Department
Standard Manufacturing - Beads
Reports to
Production Supervisor
FLSA (Exempt or Non-Exempt
Non-Exempt
Role Overview
The Beads Operator is responsible for the operation and set up of mills, granulators, drying oven, blenders, screening equipment, fluid bed dryers, feeders, etc. in accordance with company standard operating procedures. The position includes set up, operation, cleaning, and preventative maintenance of all related equipment. The Operator is accountable for overall performance including safety, quality, shrink, attainment, and production efficiency. Operators must be capable of operating multiple like machines at one time and learning to operate a variety of equipment within the manufacturing area.
Areas of Responsibility
Follows batch records, SOP’s, and cGMP's guidelines to ensure product specifications and tolerances are met.Ensures full compliance with Company policies, procedures, GMP’s, Ethical Business Practice, and SOP’s at all times. Ensures documentation such as operation logs, batch records, etc. are fully completed, signed and in compliance with company standards and regulatory requirements.Ensures that product meets applicable quality standards. This includes inspection for quality during operation and performing all required sampling and testing.Completes all labeling and inventory movements to ensure accurate inventory control.Dismantles and cleans any accessories and equipment while also maintaining a clean work area.Trains in the operation, cleaning and set-up of the following pieces of equipment as well as new equipment:Vector Fluid Bed Dryer, inserts, and ancillary equipmentK-Tron powder feederAir Classifying MillFitz mill/Multi millDouble cone/V- blenders: 6cu. ft. to 150 cu. ft. Screens/ sieves equipment Fills in appropriate logbooks for equipment and rooms.Performs all material handling of products and components.Correctly document all steps on batch record.Participates in any investigation for a deviation involving a batch record.Maintains proper gowning and hygiene to ensure integrity of the product as per company policies.Works extended hours and occasional weekend overtime.Other duties as assignedOther Responsibilities Including Safety:
Works in a safe and responsible manner to create an injury-free and incident-free workplace.Complies with all job-related safety and other training requirements. Keeps management informed of area activities and of any significant problems.Requirements
Education & Qualification:
High school graduate or GED equivalentMinimum of one (1) year work experience in nutritionals, supplements, food, or pharmaceutical manufacturing industries.Certifications, Licenses, Credentials:
N/ASkills & Ability
Demonstrates ability to work in a team and assist others.Able to follow written instructions precisely and perform basic math calculations as required.Understands and is knowledgeable of cGMP, OSHA standards, etc.Mechanically inclined to understand the inner workings of the equipment.Demonstrates the ability to read and write basic English to be able to understand the industry-regulated instruction sheets.Additional Skills and Required Technical Ability per Position Level:
Level 1
Pay Rate: $19.00 - $23.00
1-2 years experienceOperates fluid bed dryer, blending, screening & milling machines.Must be proficient in proper setup and operation of equipment in work areaLevel 2
Pay Rate: $22.00 - $24.00
2-4 years’ experience plus responsibilities aboveOperates, cleans, sets all machines in work area.A clear understanding of the principal functions of the bead department. Completes batch card independently, follow SOP’s and GMP’s strictly Certified forklift operator.Level 3
Pay Rate: $24.00 - $27.00
5+ Years’ experience plus responsibilities aboveOperates, cleans, sets all machines in work area.Must be highly skilled in the proper set up an operation of blenders and granulators.Applies cGMP’s & completes batch card instructions accurately - able to train all activities in bead manufacturing department.Ability to work with minimum to no supervision Ability to train new employeesPhysical Requirements (lifting, etc.):
Ability to lift up to 50 lbs.; occasionally lift and move up to 75 pounds.Must stand and walk on the production floor for a minimum of 6 hours per shiftUses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances.Occasionally works from a rolling ladder or step stool, must be to lean over equipment as well as kneeling on the floor to clean under the equipment.Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators.Work Environment (Office, Warehouse, temperature extremes, etc.):
Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
USPL is proud to be an Equal Opportunity Employer.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.
Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment.
Job Description
Date
06/2025
Location
1300 Airport Road, North Brunswick NJ
Title
Operator, Compression & Encapsulation
Department
Standard Manufacturing
Reports to
Production Supervisor
FLSA (Exempt or Non-Exempt
Non-Exempt
Role Overview
The Compression and Encapsulation Operator is responsible for the operation and set-up of tablet compression machines and set-up of automatic capsule filling machine in accordance with company standard operating procedures (SOPs) and cGMP regulations to ensure products meet applicable quality standards. This position includes set-up, operation, cleaning, and light mechanical adjustments. The Operator is accountable for overall production line performance including safety, quality, shrink, attainment, and line efficiency. Operators must be capable of operating multiple like machines at one time and learning to operate a variety of equipment within the manufacturing area.
Areas of Responsibility
Level 1
Makes necessary machine adjustments to ensure the smooth operation of the lines for required quality and quantity.Ensures full compliance with Company policies, procedures, GMP’s, Ethical Business Practice, and SOP’s at all times. Ensures documentation such as operation logs, batch records, etc. are fully completed, signed and in compliance with company standards and regulatory requirements.Ensures that product meets applicable quality standards. This includes inspection for quality during operation and performing all required sampling and testing.Utilizes problem-solving skills to identify and report to the team lead or supervisor troubleshoot product issues.Disassembles, cleans/ sanitizes, and reassembles all required equipment.Meets all safety expectations and follows all safety practices.Maintains proper gowning and hygiene to ensure integrity of the product as per cGMP’s and company policies.Must be able to work extended work hours and weekend overtime.Performs all other duties as assigned by immediate supervisorLevel 2
Makes necessary machine adjustments to ensure the smooth operation of the lines for required quality and quantity.Ensures full compliance with Company policies, procedures, GMP’s, Ethical Business Practice, and SOP’s at all times. Ensures documentation such as operation logs, batch records, etc. are fully completed, signed and in compliance with company standards and regulatory requirements.Ensures that product meets applicable quality standards. This includes inspection for quality during operation and performing all required sampling and testing.Utilizes problem-solving skills to investigate and troubleshoot product issues and recommend solutions for:Level 3
Makes necessary machine adjustments to ensure the smooth operation of the lines for required quality and quantity.Ensures full compliance with Company policies, procedures, GMP’s, Ethical Business Practice, and SOP’s at all times. Ensures documentation such as operation logs, batch records, etc. are fully completed, signed and in compliance with company standards and regulatory requirements.Ensures that product meets applicable quality standards. This includes inspection for quality during operation and performing all required sampling and testing.Assists supervisor in completion of deviation reports that outline both short- and long-term corrective action steps.Utilizes problem-solving skills to investigate and troubleshoot product issues and recommend solutions for:Other Responsibilities Including Safety:
Works in a safe and responsible manner to create an injury-free and incident-free workplace.Complies with all job-related safety and other training requirements. Keeps management informed of area activities and of any significant problems.LeRequirements
Education & Qualification:
Level 1
Pay Rate $19.00 - $23.00
High school graduate or GED equivalent 1-2 years Compression / Encapsulation Operator experienceCertifications, Licenses, Credentials:
N/ASkills & Ability
Demonstrates ability to work in a team and assist others.Able to follow written instructions precisely to detail and accuracy with numbers.Understands and is knowledgeable of cGMP, OSHA standards etc.Mechanically inclined to understand inner workings of equipment.Demonstrates the ability to read and write basic English in order to be able to understand the industry regulated instruction sheets.Physical Requirements (lifting, etc.):
Ability to lift up to 50 lbs.; occasionally lift and move up to 75 pounds.Must stand and walk on the production floor for a minimum of 6 hours per shiftUses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances.Occasionally works from a rolling ladder or step stool, must be to lean over equipment as well as kneeling on the floor to clean under the equipment.Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators.Work Environment (Office, Warehouse, temperature extremes, etc.):
Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
USPL is proud to be an Equal Opportunity Employer.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.
Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment.
Job Description
Date
4/2023
Location
1300 Airport Road, North Brunswick NJ
Title
Associate, Manufacturing
Department
Standard Manufacturing
Reports to
Production, Supervisor
FLSA (Exempt or Non-Exempt
Non-Exempt
Role Overview
The Manufacturing Associate is responsible for the operation and set up of one (1) machine under the guidance of a seasoned operator.
The position includes assisting with the setup, operation, cleaning, moving supplies and finish products and preventative maintenance of all related equipment. The Associate is accountable for overall performance including safety, quality, shrink, attainment, and production efficiency.
Areas of Responsibility
Ensure full compliance with Company policies, procedures, GMP’s, Ethical Business Practice, and SOP’s at all times. Ensures documentation such as operation logs, batch records, etc. are fully completed, signed to ensure product specifications and tolerances are met in compliance with company standards and regulatory requirements.Ensure that product meets applicable quality standards. This includes inspection for quality during operation and performing all required sampling and testing.Complete all labeling and inventory movements to ensure accurate inventory control.Dismantle and clean any accessories and equipment while also maintaining a clean work area.Perform all material handling of products and components.Correct document errors as needed on batch record.Maintain proper gowning and hygiene to ensure integrity of the product as per company policies.Work extended hours and occasional weekend overtime.Other duties as assigned.Other Responsibilities Including Safety:
Works in a safe and responsible manner to create an injury-free and incident-free workplace.Complies with all job-related safety and other training requirements.Keeps management informed of area activities and of any significant problems.Requirements
Education & Qualification:
High school graduate or GED equivalent.No prior experience required.Operates one (1) machine under guidance of a seasoned operator.Certifications, Licenses, Credentials:
N/ASkills & Ability
Able to work in a team and assist others.Able to follow written instructions precisely and perform basic math calculations as required.Mechanically inclined to understand inner workings of equipment.Able to read and write basic English to understand the industry regulated instruction sheets and learn all cGMP’s and OSHA standards.Physical Requirements (lifting, etc.):
Able to lift up to 50 lbs.; occasionally lift and move up to 75 lbs.Stand and walk on the production floor for a minimum of 6 hours per shift.Use hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances.Occasionally works from a rolling ladder or step stool, must be to lean over equipment as well as kneeling on the floor to clean under the equipment.Must be able to wear all PPE including a lab coat, face mask, safety shoes, gloves, safety glasses/goggles, and respirators.Work Environment (Office, Warehouse, temperature extremes, etc.):
Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
Job Description
Date
06/25
Location
1300 Airport Road, North Brunswick NJ
Title
Operator, Tablet Coating 1
Department
Standard Manufacturing
Reports to
Supervisor, Production
FLSA (Exempt or Non-Exempt
Non-Exempt
Role Overview
The Tablet Coating Operator is responsible for the operation and set-up of compression machines in accordance with company standard operating procedures (SOPs) and cGMP regulations to ensure products meet applicable quality standards. This position includes set-up, operation, cleaning, and light mechanical adjustments. The Coating Operator is accountable for overall process performance including safety, quality, shrink, attainment, and efficiency. Operators must be capable of operating multiple like machines at one time and learning to operate a variety of equipment within the manufacturing area.
Areas of Responsibility
Level 1
Level 2
Manufacture Production batches according to Batch Records, SOP’s, and cGMP guidelines to ensure product specifications and tolerances are met.Ensures full compliance with Company policies, procedures, GMP’s, Ethical Business Practice, and SOP’s at all times. Ensures documentation such as operation logs, batch records, etc. are fully completed, signed and in compliance with company standards and regulatory requirements.Ensures that product meets applicable quality standards. This includes inspection for quality during operation and performing all required sampling and testing.Check spray nozzles, piping, air pressure and boiler before start of the batch.Observes machines gauges and equipment calibration status and reports any deviations to production supervisor.Capable of running the following pieces of equipment/activity as well as train on new equipment, including troubleshooting equipment and accessories: Accela Coater – 48” & 60” Coating medium/solution preparationUtilizes problem-solving skills to investigate and troubleshoot product issues and recommend solutions for: 1) coating issues such as sticking twinning, orange peel, film peel, blistering, surface edge erosion and over - wetting 2) general issues such as coating pan set up, performance, documentation, and material issues.Responsible for proper data entry in all batch record and logbook; and in process check control during coating process.Perform all related materials handling pertaining to the products being coated.Checks and verifies weight of tablets received from compression and reports deviations.Assist in the investigation of batch record deviations.Correctly document all steps on batch record.Adhere to all company policies.Maintain proper gowning and hygiene to ensure integrity of the product as per cGMP’s and company policies.Perform cleaning of equipment and processing room and dispose of rejected tablet and powder as per compliance requirements.Knowledgeable in the relationship between spray rate, and inlet temperature, atomizing pressure, bed temperature, pan speed, and gun to bed distance.Meets all safety expectations and follows all safety practices.Works extended hours and occasional weekend overtime.Other duties as assignedLevel 3
Manufacture Production batches according to Batch Records, SOP’s, and cGMP guidelines to ensure product specifications and tolerances are met.Ensures full compliance with Company policies, procedures, GMP’s, Ethical Business Practice, and SOP’s at all times. Ensures documentation such as operation logs, batch records, etc. are fully completed, signed and in compliance with company standards and regulatory requirements.Ensures that product meets applicable quality standards. This includes inspection for quality during operation and performing all required sampling and testing.Check spray nozzles, piping, air pressure and boiler before start of the batch.Observes machines gauges and equipment calibration status and reports any deviations to production supervisor.Capable of running the following pieces of equipment/activity as well as train on new equipment, including troubleshooting equipment and accessories: Accela Coater – 48” & 60” Coating medium/solution preparationAssist in the revision and creation of department SOP’s.Utilizes problem-solving skills to investigate and troubleshoot product issues and recommend solutions for: 1) coating issues such as sticking twinning, orange peel, film peel, blistering, surface edge erosion and over - wetting 2) general issues such as coating pan set up, performance, documentation, and material issues.Responsible for proper data entry in all batch record and logbook; and in process check control during coating process.Perform all related materials handling pertaining to the products being coated.Checks and verifies weight of tablets received from compression and reports deviations.Assist in the investigation of batch record deviations.Correctly document all steps on batch record.Adhere to all company policies.Maintain proper gowning and hygiene to ensure integrity of the product as per cGMP’s and company policies.Perform cleaning of equipment and processing room and dispose of rejected tablet and powder as per compliance requirements.Knowledgeable in the relationship between spray rate, and inlet temperature, atomizing pressure, bed temperature, pan speed, and gun to bed distance.Meets all safety expectations and follows all safety practices.Works extended hours and occasional weekend overtime.Other duties as assignedOther Responsibilities Including Safety:
Works in a safe and responsible manner to create an injury-free and incident-free workplace.Complies with all job-related safety and other training requirements.Keeps management informed of area activities and of any significant problems.Requirements
Education & Qualification:
Level 1
Pay Rate: $21.00 - $25.00
High school graduate or GED equivalent 1-2 years of experienceLevel 2
Pay Rate: $23.00 - $28.00
High school graduate or GED equivalent 2-4 years of experienceOperate 2 machines at one timeA clear understanding of the principal coating pan operation. Responsible for trainingLevel 3
Pay Rate: $28.00 - $38.00
High school graduate or GED equivalent 5+ years of experienceOperate all machines.Solution prep, able to coat / troubleshoot the problems for all products.A thorough understanding of the causes and prevention of common coating problems.Responsible for trainingAbility to work with minimum to no supervisionCertifications, Licenses, Credentials:
N/ASkills & Ability
Demonstrates ability to work in a team and assist others.Able to follow written instructions precisely and perform basic math calculations as required.Understands and is knowledgeable of cGMP, OSHA standards, etc.Mechanically inclined to understand the inner workings of the equipment.Demonstrates the ability to read and write basic English to be able to understand the industry-regulated instruction sheets.Must have attention to detail.Physical Requirements (lifting, etc.):
Ability to lift up to 50 lbs.; occasionally lift and move up to 75 pounds.Must stand and walk on the production floor for a minimum of 6 hours per shiftUses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances.Occasionally works from a rolling ladder or step stool, must be to lean over equipment as well as kneeling on the floor to clean under the equipment.Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators.Work Environment (Office, Warehouse, temperature extremes, etc.):
Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
USPL is proud to be an Equal Opportunity Employer.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.
Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment.
