Reliability Technician / Mechanic
Full Time
NY-Chestnut Ridge Site, Chestnut Ridge, NY, US
Job Summary
The Pharmaceutical Maintenance Mechanic II performs facility reliability maintenance activities in accordance with approved procedures requiring limited supervision. Proficient at analyzing and troubleshooting the root cause of facility, manufacturing and packaging equipment problems. Implements effective preventive and/or corrective maintenance repairs to provide increased reliability. Identifies maintenance improvements that increase efficiency, throughput, and quality. May train others in setting up equipment. Identifies and solves complex problems. Understands the practical application to problems and situations ordinarily encountered and makes decisions that require choosing from several options.
Knowledge
Has a wide range of technical skills and operational knowledge in procedures, techniques, tools, materials and/or needed equipment.Understands the practical applications to problems and situations ordinarily encountered.Fully knowledgeable of cGMP regulations and processes.Knowledge of equipment capabilities and the ability to train others.Knowledge of processes described in SOPs, where to find and how to use SOPs, and have the ability to train others in relevant SOPs and documentation.Skills & Abilities
Qualified with appropriate certifications, as required, and demonstrates competence in equipment maintenance, repair and set-up.Ability to troubleshoot independently.Ability to assess and perform PM tasks and train others in this area.Ability to read schematics, technical drawings, and blueprints.Interfaces with external vendors and service providers. May be required to be proficient in troubleshooting & repair in 4 or more of the following areas:ElectricalHydraulicsPneumaticsMechanicalPLC'sProficient in following areas:Ability to read and follow blueprints and engineered drawings.Ability to use the BMS (Bldg. Management System) for HVAC.Specialized in at least 4 of the following 5 areas:Utility – purified water systems, compressed air, boiler, chilled water, electrical distribution, product dust collection systems.Building Maintenance – sewers, electronic card readers (when applicable), lighting.Fire suppression systems.HVAC competence and certification, as required.General building & grounds maintenance.Basic math, writing skills, problem solving.Basic computer skills.Ability to use hand tools.Control Precision - ability to quickly and repeatedly adjust the controls of a machine to exact positions.Education & Experience
GeneralA High School Diploma or equivalent is required.Level 3 TechSeven years related experience and certification in assigned area(s), as required.ACCP-Level II Certification or equivalent experienceThis position is a 2nd shift role. Hours will be 3 pm to 11.30 pm
Read LessJob Description:
Primary responsibilities of this role include the following:
With Supervision, review documents/records and provide batch release authorization to 3PL service provider for products manufactured outside of the USSupport Drug Product Complaint management; forwarding to respective drug product manufacturing site and coordinate with corporate QA for investigations.Support Drug Product recall/field alert management.Assist with review of Quality AgreementsFor applicable products, coordinate with Contract Testing Laboratories for Analytical Method Transfer activities, Drug Product testing, any OOS results, and test method issues.With supervision, review deviations/investigations related to Strides Pharma Inc (Strides) frontend products.Assist with SOP management for Strides’ US corporate office.
QUALIFICATIONS
Education & Experience
Bachelor’s degree in Pharmacy, Chemistry, Biology or Microbiology is preferred 1 to 2 years of Quality Assurance or related pharmaceutical industry experience is preferred. Recent graduates will be considered for this role.Knowledge & Skills
Excellent verbal and written communication skills are necessary.With supervision and direction, effectively prioritizes competing tasks in a fast-paced and dynamic environmentMotivated, results driven with attention to detail, accuracy and clarity.
Physical Requirements
General Office environment Read LessPOSITION SUMMARY
Oversee physical/chemical/microbiological testing and analyses of pharmaceutical raw materials, excipients and finished drug products, including release, stability testing, cleaning verification test, and in-process testing. Supervise daily work of Chemists, Microbiologists and Technicians; provide guidance and directions when necessary. Conduct lab investigations and prepare deviations as needed.
ESSENTIAL FUNCTIONS
Testing
Execute work schedule, review analysts’ notebooks and supervise analysts in day-to-day operations to ensure the compliance of SOP, cGMP, GLP, DEA regulations and/or MSDS.Understand analytical instrument operation/maint. of HPLC, UV-Vis, FT-IR, GC, dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Expert in analytical instrumentation to assure quality of test results.Review notebooks and instrument logbooks. Release test results to QA or other departments in a timely manner.Ensure timely completion of stability testing, provide data to regulatory groups, and conduct data trending during product shelf life.Perform methods development, transfer, verification and validation activities. Coordinate and assist with evaluation of Process Validations studies.Documentation Practice, Training and Compliance
Ensure work of staff is in compliance with good documentation practices per company's SOP and cGMP regulations in the laboratory. Prepare and review laboratory documents such as Laboratory Deviations, Investigations, and Test Methods in a timely manner.Enforce all applicable safety and standards guidelines, DEA regs and/or MSDS in lab. Ensure analysts are trained properly before they conduct corresponding testingLab Maintenance
Perform housekeeping on regular basis. Oversee general lab support; sample receiving, chemical inventory and document filing.Enforce safety by ensuring wearing of lab coat, safety shoes, safety glasses while in lab.Monitor ordering of lab supplies.Enforce the control and management of controlled substances.
Staff development
Evaluate potential candidates for QC; prepare annual performance evals. for chemists. Prepare chemists and laboratory for FDA and other compliance audits.Ensures adequate resources are trained to support compliance and business initiatives.
QUALIFICATIONS
Education & Experience
BS in chemistry, biochemistry, pharmacy, or related discipline. Advanced degree a plus.7+ years of experience in pharmaceutical laboratory.2+ year QC supervisory experience preferred.Knowledge & Skills
Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.Proficiency required with laboratory techniques/instruments, such as pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, HPLC or GC and analytical balance, etc.Analytical - Synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data; designs work flows and procedures.Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills; shares expertise with others.Interpersonal Skills - Focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; open to other ideas and tries new things.Planning/Organizing – Prioritizes/plans work; uses time efficiently; plans for additional resources; sets goals/objectives; organizes/schedules other people and tasks; develops realistic action plans.Safety and Security - Observes safety and security procedures; determines appropriate action beyond guidelines; reports potentially unsafe conditions; uses equipment and materials properly.Dependability - Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time or notifies appropriate person with an alternate planInitiative - Volunteers readily; undertakes self-development activities; seeks increased responsibilities; takes independent actions and calculated risks; looks for and takes advantage of opportunities; asks for and offers help when needed.Good verbal and written communication with basic computer skills.Physical Requirements
Extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, moderate noise levels and some bus. travel. Work is performed in a FDA and DEA-regulated pharmaceutical lab environment with risk of exposure to various chemicals.Must occasionally lift and/or move up to 25 pounds. Lab coat and safety glasses required in work environment.Specific visions abilities are required by this job include close vision and color vision.The noise level in the work environment is usually moderate.The work environment is representative of a group laboratory environment.Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Read LessPosition summary
The Quality Associate I, Operations is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging. Quality activities include product sampling and inspection, area clearance to confirm process readiness, non-conforming event support to resolve in-process issues, and process validation and qualification activities. Communicates to multiple departments and supervision to provide timely process and issue updates. Identifies and escalates issues or problems to appropriate supervision. Participates as a team member on cross-functional teams. Participates in reviews and structured processes for continuous improvement
Roles and Responsibilities
Performs physical inspection of in-process and finished product samples as assigned and according to the production schedule Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements Is competent in all relevant processes (weighing, compounding, mixing, packaging, granulation, compression, coating, Liquids Mfg. and Batch Transfer, Creams & Ointments Mfg. and Batch Transfer, Packaging, etc.) Follows internal processes related to controlled substances Performs GMP-related verifications including area, equipment and line clearances, cleaning, room inspection, material verification, etc. according to procedures Actively participates in process validation and equipment qualification activities May execute computer data entries in SAP, Leucine, LIMS, and department databasesSampling and inspection of raw materials, packaging components, in-process, bulk, and finished drug product during manufacturing and packaging operations of commercial and non-commercial processes Performs manufacturing/packaging stage reviews of batch records
Education & Experience
High school diploma or equivalent with 4-7 years’ relevant experience OR AA/AS degree with 3-6 years’ relevant experience OR BA/BS degree with 2 -5 years’ relevant experience Related discipline and certification in assigned area a plus Experience with statistical sampling methods a plusKnowledge & Skills
Attention to detail Strong documentation skills Ability to read and interpret SOPs and function within the scope of procedures Proficiency with basic math skills and basic experience with computers and software applications required Ability to learn new processes and proceduresAble to communicate effectively with other departments, management and operational personnel Customer/Stakeholder focused (understands impact of daily work to compliance and overall business) Proof-reading skills; ability to identify errors Ability to read and comprehend documentation and requirements set forth in Batch Production Records (BPRs)Experience with Enterprise Resource Planning (ERP) system is a bonusAbility to work overtime as needed, including occasional weekend shifts
Physical Requirements
Lift 15 lbs. Walk across plant/warehouse Wear appropriate gowning as required Ability to read for extended periods of time
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Read LessPosition Summary
The QA Associate supports the site’s Quality Management System by managing product complaints, adverse events, and investigation activities. This role contributes to deviation and CAPA processes, audit support, and regulatory compliance efforts, while assisting with quality metrics, trend analysis, and continuous improvement initiatives
ESSENTIAL FUNCTIONS
Product Quality Complaints:
Serve as the site point of contact for handling, managing, and performing product quality complaint investigations. Responsible for maintaining communication with patients and third parties to ensure all needs of the product quality complaint investigation are met and delivered to the respective party.Adverse Events/ Pharmacovigilance
Responsible for maintaining, managing, organizing, and ensuring adverse events and pharmacovigilant activities are appropriately addressed and triaged to the correct responsible party. Responsible for understanding and defending the methods and modes in which adverse events, product inquiries, and other pharmacovigilant activities are addressed.Root Cause Investigations (Deviations and CAPAs)
Serves as a subject matter expert for root cause investigation guidelines includingAssists in ensuring investigations and CAPAs adhere to SMART principles and drive site wide continuous improvement activities.Responsible for developing, managing, and executing CAPA effectiveness checks, to ensure that the site is committed to improvement and to identify additional areas of improvement when applicable.FAR
Serves as a backup to facilitate the field alert reporting process as a process subject matter expert. Responsible for maintaining an accurate and informative log of field alerts and market actions for site trending and documentation.Audit Scribing
Serves as a point of contact to facilitate internal and external audits and communication with auditors. Specifically, serves as audit scribe to ensure that the audit activities are performed and executed in a controlled and efficient manner.Trending Reports/ Metrics
Responsible for completing annual trending reports for different corners of the quality management system, including deviations, CAPAs, and complaints. Trend reports will be developed with the year in review of data, to drive and address areas subject to continuous improvement.Metrics
Responsible for working with cross functional groups to acquire and maintain period data and metrics to deliver in clear, concise, and effective metric reports. Use entry level statistical analytical methods to determine effectiveness of systems and highlight areas for improvement.Change Controls
Serves as a back-up to the change control process as a change control coordinator. Assists with the management of the change control schedule and agenda, the review of and the approval of change controls. Serves as a subject matter expert to ensure site change controls adhere to proper regulatory requirements and site guidelines.QUALIFICATIONS
Education & Experience
Bachelor’s degree in Pharmaceutical Sciences, Pharmacy or a related field. 1–3 years of experience in Quality Assurance within a pharmaceutical or regulated environmentFamiliarity with QMS platforms and electronic documentation systems preferred.Knowledge & Skills
Ability to communicate and work with teams Attention to detail Strong documentation skills Basic knowledge of GMP, deviations, CAPA, and change control processes Understanding of pharmacovigilance and product complaint handling preferred Ability to analyze data and support trending/metric reporting Proficiency in Microsoft Office (Excel, Word, PowerPoint)Ability to read and interpret SOPs and function within the scope of procedures Customer/Stakeholder focused (understands impact of daily work to compliance and overall business) Proof-reading skills; ability to identify errors Ability to read and comprehend documentation and requirements set forth in Batch Production Records (BPRs)Ability to work overtime as needed, including occasional weekend shiftsPhysical Requirements
Lift 15 lbs. Walk across plant/warehouse Wear appropriate gowning as required Ability to read for extended periods of time
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Read LessPOSITION SUMMARY
The Manufacturing Operator III performs functions relating to the processing of drug products, ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements and in conjunction with all Standard Operating Procedures (SOPs). This is a Lead role, is considered a process expert, and is a Certified Trainer of other Operators. This role supervises the day-to-day activities of the Operators and provides guidance on tasks that are being performed on the line. Often, this position is involved in the Operator interview process but are not decision makers in terms of hiring decisions, promotions, annual evaluations, etc. Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. Applies skills and knowledge to recognize process issues and to increase efficiency, throughput, and quality. Proactively identifies and resolves complex problems where considerable judgment is required in choosing among multiple options. Troubleshoots process issues, analyzes root causes, and makes recommendations. Understands and runs processes to meet the assigned standards/routers and fulfills the assigned schedule; when these are not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward. Troubleshoots process issues and, as a team member, analyzes root causes and makes recommendations. Responsible for the safe and efficient execution of job duties. May serve as back-up to the Senior Manufacturing Technician.
ESSENTIAL FUNCTIONS
Manufacturing Process
A depth of knowledge in fluid bed dryer operations is required to be able to operate and troubleshoot fluid bed dryer operations.Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, dispensing, mixing, coating, encapsulating, granulating, drying, milling, blending, compressing. Meets requirements for use of manufacturing equipment and other commonly used equipment per SOP’s. Executes written SOP’s to ensure the purity of materials involved in the manufacturing process Properly uses all scales, including printouts, zeroing, setting tares, and daily calibration verification per SOP’s Examines manufacturer Product ID Labels, Quality Control release tags, and Batch Production Record to verify issued/staged raw materials can be released for production Cleans manufacturing equipment and facilities according to established SOPs Executes machine change-overs from batch to batch Completes a variety of assignments independently based on established procedures Identifies process improvements that drive increased efficiency, throughput and quality Samples batches, including validation batches, for quality testing Executes required in-process product quality checks and documents accurately With Master Clean/Surface Clean certification, releases room to be master and/or surface cleaned Understands and runs processes to meet the assigned schedule and standards/routers; when this is not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forwardDocumentation
Completes documentation associated with manufacturing processes (e.g. batch record and logbooks) with detail and accuracy Meets requirements for entries on all applicable Batch Production pages, completion and attachment of all dispensary and weight verification tickets Verifies the manufacturing process on BPR in an accurate and timely manner Provides status updates and operational challenges on status boardsContinuous Improvement
Proactively identifies and troubleshoots process issues and, as a team member, analyzes root causes and makes recommendations. Typically participates in Continuous Improvement projects of a higher scope & complexity
Safety and Compliance
Carries out processing/manufacturing activities safely, as required, on a daily basis. Follows all safety and compliance procedures and participates in required training Adheres to all cGMP compliance/regulatory mandates and quality requirements. Participates in safety teams, start-up discussions, incident debriefs, etc. Ensures compliance with SOPs, Policies and Procedures as required by Company and regulatory agencies Maintains a clean, organized work area.Training
Conforms to all training requirements, including company required and machine specific training. May become a certified trainer and provide mentoring and training.Teamwork and Collaboration
Exhibits teamwork and motivates others to achieve project objectives. Collaborates within own work unit and with those from other departments outside of work unit and/or with external vendors/suppliers.QUALIFICATIONS
Education & Experience
HS diploma with 5 years’ Pharmaceutical Manufacturing Operator experience & certification in assigned area, as required Forklift certification is required for certain jobs.Knowledge & Skills
Knowledge of cGMPs Basic math, writing skills, and problem-solving abilitiesHas a wide range of technical skills and operational knowledge Understands the practical applications to problems and situations ordinarily encountered Proficiency in operating Fluid Bed Dryers or equivalent.Proficient in (Master Clean/Surface clean) equipment Proficient in setting up machinery Proficient in trouble shooting Ability to become a certified trainer and provide certified training in one process Ability to effectively interface with other departments if senior level (4th level) isn’t available Ability to participate in Continuous Improvement projects Qualified in both Weighing or Blending (where applicable) and at least in 1 of the following manufacturing processes: Granulation Compression Coating EncapsulationPotent Compound Safety and Security Observes safety and security procedures. Determines appropriate action beyond guidelines. Reports potentially unsafe conditions. Uses equipment and materials properly.Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.Attendance/Punctuality – Is consistently at work and on time; Arrives at meetings and appointments on time.Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.Written Communication – Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information. Oral Communication - Speaksclearly and persuasively inpositive or negative situations;listens and gets clarification;Responds well to questions;Demonstrates group presentationskills; Participates in meetings.Comply with all Company policiesand procedures.
Physical Requirements
Must be able to stand for long periods of time (up to 12 hour shifts), lift at least 50 pounds, climb ladders, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes. Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects Vision - ability to see details at close range (within a few feet of the observer) Hearing - ability to detect or tell the differences between sounds that vary in pitch and loudness Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Read LessPOSITION SUMMARY
With thorough knowledge and skills in all areas of the packaging process, performs more advanced functions relating to the packaging of drug products consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP). Is qualified in both Filling and Labeling. Is qualified and capable of competently running all packaging equipment across the entire packaging department. Responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards. May serve as back-up to the Senior Packaging Technician.
ESSENTIAL FUNCTIONS
Packaging Operations
Is qualified and capable of competently running all packaging equipment across the entire packaging department Is qualified in both Filling and Labeling Ensures that all equipment is running properly Executes processes such as: material handling, capping, outserts/med guides, in-process checks, packing, stacking, cartoning, etc. May request components, labels and inserts per the BPR Sets up packaging machinery; accurately sets equipment programming according to BPR's and SOP's Sets up, starts, operates, adjusts, troubleshoots and tears down packaging lines Executes Batch Production Record (BPR) and logbook documentation with detail and accuracy Accurately reviews BPR's steps for completeness and accuracy Collects samples from each batch and submits to QA for retained samples Demonstrates the ability to execute procedures and complete tasks in a compliant and safe mannerEquipment Cleaning
Conducts verification of line/equipment cleaning and documents per SOP Executes the procedures used to clean pharmaceutical packaging equipment and facilities Conducts Master Cleans and Surface CleansContinuous Improvement
Identifies 6S opportunities and sustains the 6S process Assists in troubleshooting process issues
Issues and Deviations
Identifies and reports processing related issues to Packaging Supervisor and to Quality personnel.Quality
Executes the required in-process product quality checks and documents accurately.
Teamwork and Collaboration
Demonstrates the ability to work in collaboration with others as a part of a team.
Training
Stays current on SOPs and cGMPs. May participate in training qualifier classes.
Safety and Compliance
Participate in safety teams, start-up discussions, incident debriefs, etc. Carries out processing/packaging activities safely, as required, on a daily basis. Follows all safety and compliance procedures and participates in required training. Adheres to all cGMP compliance/regulatory mandates and quality requirements. Ensures compliance with SOPs, Policies and Procedures as required by Par and regulatory agenciesMisc.
Other related duties as assigned to meet departmental and Company objectives.
QUALIFICATIONS
Education & Experience
High school diploma or equivalent. 3 years of packaging experienceKnowledge & Skills
Knowledge of cGMP regulations and processes.Qualified in both Filling and Labeling Qualified and capable of setting up and running all machinery in the value stream Competent in Master Clean/Surface Clean Ability to sample batches Ability to follow both verbal and written instructions including SOP’s and Batch Record documentation Ability to accurately and precisely record data and batch information Ability to work in both independent and team environments May become a certified trainer and provide certified training in one process Effectively interfaces with other department personnel if Senior level (4th level) isn’t availableAbility to troubleshoot process issues Ability to Identify 6S opportunities and sustain the 6S process Ability to participate in Continuous Improvement projects Proficient in reading and writing English to understand work instructions and document resultsPhysical Requirements
Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes. Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects. Vision - ability to see details at close range (within a few feet of the observer). Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Read LessPosition summary
The DEA Manager is responsible for ensuring the company maintains strict compliance with all DEA regulations and applicable state-level controlled substance laws. This role manages the day-to-day requirements for handling controlled substances, including quota management, licensing, ARCOS reporting, Suspicious Order Monitoring (SOM), material movement, and maintaining accurate records to ensure audit readiness at all times
Roles and Responsibilities
Manages a team supporting State Licensing, Suspicious Order Monitoring (SOM) and DEA.Manages and submits DEA procurement quota applications.Maintains and renews DEA, State, and Board of Pharmacy licenses and registrations for all company facilities. Oversees the generation and execution of DEA 222 forms for the transfer and procurement of Schedule II controlled substances.Acts as the primary point of contact during DEA and State Board of Pharmacy inspections and audits. Liaises with Procurement and the DEA regarding the import/export of control substances and completes required documentation. Prepares, reviews, and submits accurate and timely ARCOS reports to the DEA; Ensures accurate reporting of year-end and biennial inventories across all facilities. Conducts internal audits of controlled substance vaults, cages, and manufacturing areas to ensure physical security and record-keeping compliance. Drafts, reviews, and updates Standard Operating Procedures (SOPs) related to the handling, storage, and distribution of controlled substances. Monitors federal and state legislative changes regarding controlled substances; advises management on the impact of new regulations and implement necessary operation shifts.Coordinates all controlled substance destruction with the warehouse and the Environmental, Health & Safety department.Education & Experience
Bachelor’s degree in Science, PharmD preferred5+ years of relevant work experience Strong knowledge of DEA and FDA regulationsPhysical Requirements
Ability to stand, walk, or climb stairs/ladders for extended periods while performing duties within the plant.Occasional lifting or moving of materials or equipment (generally up to 25–40 lbs).Frequent use of hands and eyes for computer work, and documentation.Ability to wear required personal protective equipment (PPE) such as safety glasses, gowns, gloves, or respirators when entering manufacturing areas.Capacity to work in cleanroom environments, which may involve temperature variations, or noise.Must be able to travel between facilities as needed
Read LessJob Summary -
The Manufacturing Operator III – Granulation performs functions relating to the processing of drug products, ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements and in conjunction with all Standard Operating Procedures (SOPs). Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing. Applies skills and knowledge to recognize issues and to increase efficiency, throughput and quality. Proactively identifies and resolves complex problems where considerable judgment is required in choosing among multiple options. Understands and runs processes to meet the assigned standards/routers and fulfills the assigned schedule; when these are not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward. Troubleshoots process issues and, as a team member, analyzes root causes and makes recommendations. Responsible for the safe and efficient execution of job duties. May serve as back-up to the Senior Manufacturing Technician.
Manufacturing Operations work unit at the various Strides locations listed above
Accountability / Responsibilities
Manufacturing Process
Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, mixing, granulating, drying, milling, blending, potent compound, etc. Meets requirements for use of manufacturing equipment and other commonly used equipment per SOPs. Executes written SOPs to ensure the purity of materials involved in the manufacturing process.Properly uses all scales, including printouts, zeroing, setting tares, and daily calibration verification per SOPs.Examines manufacturer Product ID Labels, Quality Control release tags, and Batch Production Record to verify issued/staged raw materials can be released for production.Cleans manufacturing equipment and facilities according to established SOPs.Executes machine change-overs from batch to batch.Completes a variety of assignments independently based on established procedures.Identifies process improvements that drive increased efficiency, throughput and quality.May sample batches, including validation batches, for quality testing.Executes required in-process product quality checks and documents accurately.Understands and runs processes to meet the assigned schedule and standards/routers; when this is not achieved, participates in the debriefing sessions to understand the reasons why and what needs to be corrected moving forward.Documentation
Completes documentation associated with manufacturing processes (e.g. batch record, protocol, and logbooks and E-logs) with detail and accuracy. Meets requirements for entries on all applicable Batch Production pages, completion and attachment of all dispensary and weight verification tickets.Verifies the manufacturing process on BPR in an accurate and timely manner.Provides status updates and operational challenges.Continuous Improvement
Proactively identifies and troubleshoots process issues and, as a team member, analyzes root causes and makes recommendations. Typically participates in Continuous Improvement projects of a higher scope and complexity.Safety & Compliance
Carries out processing/manufacturing activities safely, as required, on a daily basis. Follows all safety and compliance procedures and participates in required training.Adheres to all cGMP compliance/regulatory mandates and quality requirements.Participates in safety teams, start-up discussions, and incident debriefs, etc.Ensures compliance with SOPs, policies and procedures as required by the Company and regulatory agencies.Maintains a clean, organized work area.Continuous Training
Conforms to all training requirements, including company required and machine specific training. May become a certified trainer and provide mentoring and training.Teamwork and collaboration
Exhibits team work and motivates others to achieve project objectives.Collaborates within own work unit and with those from other departments outside of work unit and/or with external vendors/suppliers.Education & Experience
HS diploma or equivalent at minimum, with 2-3 years’ related experience*Forklift certification may be required for blending and granulation.Knowledge
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
Knowledge of cGMPs.Basic math, reading, legible writing skills, and problem solving abilities.Has thorough knowledge and skills in the processes noted below. Has a wide range of technical skills and operational knowledge.Understands the practical applications to problems and situations ordinarily encountered.Skills & Abilities
Proficient in running machinery.Proficient in (Master Clean/Surface clean) equipment cleaning. Proficient in setting up machinery.Proficient in trouble shooting.Ability to become a certified trainer and provide certified training in one process.Ability to effectively interface with other departments if senior level (4th level) isn’t available. Ability to participate in Continuous Improvement projects. Posesses capability to be Qualified in multiple locations within the Granulation department and/or cross trained in Blending (where applicable) and at least one of the following manufacturing processes:GranulationCompressionCoatingEncapsulationPotent CompoundSafety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.Attendance/Punctuality - Is consistently at work and on time; Arrives at meetings and appointments on time.Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.Comply with all Company policies and procedures.Comply with all Company safety rules and regulations.
Physical Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
Must be able to stand for long periods of time (up to 12 hour shifts), maneuver at least 50 pounds, climb ladders, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects.Vision - ability to see details at close range (within a few feet of the observer).Hearing - ability to detect or tell the differences between sounds that vary in pitch and loudness.Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing. Read LessJOB SUMMARY
The Chemist II, under minimal supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation. Has demonstrated competence in conducting all types of physical and chemical analyses (including complex analyses) using all equipment. Detects, conducts, and reports on OOS/OOT/NOE and other investigations. Learns and stays current with regulatory guidance and compendia relevant to laboratories and pharmaceutical manufacturing. Participates in troubleshooting analyses and instrumentation. Trains less senior staff.
All incumbents are responsible for following applicable Division & Company policies and procedures.
KEY ACCOUNTABILITIES
Analysis & Testing
Conducts laboratory analyses according to approved test methods: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses Reviews and approves laboratory test data and documentation for completeness and compliance Is alert to and detects abnormalities during performances of tests and reviews. Elevates abnormalities to Supervisor Performs lab methods transfer and participate in method validation/verification studiesLab Equipment
Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals Troubleshoots instrument/chromatography problems and identifies improvements/CAPAsInvestigations
Detects, conducts and reports on OOS/OOT/NOE and other investigations Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action Writes, edits and reviews SOPs and laboratory investigationsTraining
Maintains assigned training records current and in-compliance Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and proceduresCompliance
Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs Follows internal processes related to controlled substancesSafety
Follows EH&S procedures to ensure a safe work environment Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDSQUALIFICATIONS
Education & Experience
Bachelor of Science Degree in chemistry, chemical engineering or related field with 4+ years’ relevant analytical laboratory experience OR Master’s Degree in above disciplines with 2+ years’ relevant analytical lab experienceKnowledge
Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Thorough knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS Has demonstrated competence in conducting chemical analyses Strong knowledge of wet chemistry techniques Competency in Microsoft Office SuiteSkills & Abilities
Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information, reporting to management Ability to display and analyze data in a logical manner Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information Ability to display and analyze data in a logical manner Strong verbal and written communication skills as well as good computer skills Strong attention to details and accurate record keeping Establish and maintain cooperative working relationships with others Solid organizational skills Ability to coach less senior staff and develop laboratory skills and ability Ability to take initiative, set priorities and follow through on assignments Read Less