QA Inspector
About KVK Tech
KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
What You’ll Do
The QA Inspector is responsible for performing in-process and final inspections on the production and packaging floors to ensure products meet quality standards and regulatory requirements. This position provides real-time quality oversight, ensuring all operations comply with established procedures, documentation practices, and data integrity expectations.
Key Responsibilities:
• Perform in-process inspections, component verifications, and line clearances in accordance with approved SOPs and batch records.
• Monitor manufacturing and packaging operations to ensure adherence to cGMP and internal quality procedures.
• Inspect raw materials, in-process samples, finished products, and labeling to verify conformance with specifications.
• Review batch production, cleaning, and packaging records for accuracy, completeness, and compliance prior to QA release.
• Document inspection results, deviations, and nonconformances accurately and contemporaneously.
• Assist with deviation investigations, CAPAs, and quality event documentation under QA management direction.
• Support audits, internal inspections, and continuous improvement initiatives.
• Collaborate closely with Production, Engineering, and Quality departments to address quality concerns promptly.
• Maintain data integrity and ensure documentation meets ALCOA+ principles at all times.
• Perform other related QA responsibilities as required to meet departmental objectives.
What We’re Looking For
Experience: 1–3 years of Quality Assurance or Quality Control experience in a GMP-regulated pharmaceutical, biotechnology, or related manufacturing environment.
Education: High school diploma or equivalent required; Associate degree or coursework in Life Sciences, Chemistry, or a related discipline preferred.
Skills & Knowledge:
• Strong understanding of current Good Manufacturing Practices (cGMP) and FDA compliance requirements.
• Knowledge of quality inspection techniques, sampling methods, and documentation review.
• Experience with batch record review, line clearance, or in-process inspection preferred.
• High attention to detail with the ability to detect and resolve nonconformances.
• Proficiency in Microsoft Office (Word, Excel, Outlook) and standard documentation systems.
• Excellent written and verbal communication skills; able to interact effectively across teams.
• Strong time-management, organization, and follow-through abilities.
• Ability to work independently while maintaining a high standard of accuracy and accountability.
What We Offer
• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Career growth opportunities
• Professional development reimbursement
• Tuition reimbursement for children and childcare expense reimbursement
Schedule
• Full-time, on-site position (M-F 7:00 am - 3:30 pm)
\nCompany DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
Company DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products. Read LessAbout KVK Tech
KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
What You’ll Do
The Document Control Associate supports the Quality Management System by maintaining accurate, current, and controlled GMP documents and records. This role administers the formatting, issuance, retrieval, archival, and lifecycle control of SOPs, batch records, protocols, reports, controlled forms, and logbooks. The Document Control Associate works closely with Quality Assurance and cross-functional departments to ensure documentation is complete, readily retrievable, and maintained in compliance with cGMP, Good Documentation Practices, and data integrity requirements.
Key Responsibilities:
Administer document control activities for SOPs, batch records, protocols, reports, work instructions, controlled forms, and related GMP documents within MasterControl or the applicable document management system.Format and process new or revised controlled documents in accordance with approved templates, workflows, SOPs, and document control procedures.Issue, retrieve, reconcile, file, archive, and maintain controlled batch records, protocols, forms, logbooks, and other GMP records.Review submitted documents and executed records for completeness, legibility, required information, and proper document status before filing or archival.Scan, index, and maintain organized physical and electronic document files to ensure accurate and timely record retrieval.Maintain document control logs, tracking spreadsheets, and metrics while supporting document reviews, audits, regulatory inspections, and assigned Quality System activities.What We’re Looking For
Experience:
0–3 years of experience in document control, records management, quality assurance, data entry, or administrative support.Experience in a pharmaceutical, biotechnology, or other cGMP-regulated manufacturing environment preferred.Experience with an electronic document management system such as MasterControl or an equivalent platform preferred.Education:
High school diploma or equivalent required.Associate degree in Science, Business, Records Management, Quality, or a related field preferred.Skills & Knowledge:
Basic understanding of document control, cGMP, Good Documentation Practices, and data integrity principles, or the ability to learn these requirements.Proficiency with Microsoft Office applications, including Word, Excel, and Outlook.Strong attention to detail, accuracy, organization, and document-management skills.Ability to perform accurate data entry, scanning, indexing, filing, and records-retrieval activities.Effective written and verbal communication skills with the ability to manage multiple priorities and collaborate with cross-functional teams.What We Offer
Competitive hourly compensation with annual performance bonus eligibilityAnnual merit-based pay increasesAutomatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributedPaid Time Off10 paid company holidaysComprehensive medical, dental, vision, and life insurance coverageProfessional development reimbursementCareer growth opportunitiesTuition reimbursement for children and childcare expense reimbursementSchedule
Full-time, on-site position (Monday–Friday, 8:00 AM–5:00 PM)\nCompany DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
Company DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products. Read LessPackaging Operator I
About KVK Tech
KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
What You’ll Do
The Packaging Operator I supports routine packaging operations for oral solid dosage pharmaceutical products by operating assigned equipment, performing in-process checks, and maintaining accurate documentation. This role follows established SOPs and cGMP requirements to ensure product integrity, safety, and regulatory compliance while supporting efficient daily production activities on the packaging floor.
Key Responsibilities:
• Operate assigned packaging equipment in accordance with SOPs, including loading components, monitoring performance, and tending machines throughout production runs.
• Perform start-up and shut-down procedures for packaging equipment at the beginning and end of each shift.
• Conduct in-process quality checks to verify packaging accuracy, integrity, and adherence to specifications.
• Make minor equipment adjustments as permitted to maintain consistent product quality and minimize downtime.
• Accurately complete batch records, logs, and documentation in compliance with cGMP and data integrity requirements.
• Perform routine cleaning, sanitation, and end-of-line activities for equipment and work areas following approved procedures.
• Follow all safety requirements and promptly report equipment malfunctions, quality issues, or unsafe conditions to supervision.
What We’re Looking For
Experience: 0–2 years of experience in a regulated manufacturing or packaging environment preferred; prior pharmaceutical experience is a plus.
Education: High school diploma or equivalent preferred.
Skills & Knowledge:
• Ability to read, understand, and follow batch records, SOPs, and work instructions.
• Basic mechanical aptitude with the ability to perform minor equipment adjustments.
• Strong attention to detail and commitment to following procedures accurately.
• Effective verbal and written communication skills.
• Ability to work collaboratively in a team-oriented production environment.
What We Offer
• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Professional development reimbursement
• Career growth opportunities
• Tuition reimbursement for children and childcare expense reimbursement
Schedule
Full-time, on-site position (3:30pm-12:00am) with flexibility for occasional overtime during peak production cycles.
\nCompany DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
Company DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products. Read LessAbout KVK Tech
KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
What You’ll Do
The QC Documentation Associate is a member of KVK Tech’s Quality Control (QC) Chemistry department and is responsible for maintaining accurate, complete, and compliant documentation throughout the QC data lifecycle. This role prepares and maintains analytical methods, test procedures, product specifications, controlled spreadsheets, and Empower calculations in accordance with cGMP requirements and ALCOA+ data integrity principles. The QC Documentation Associate also tracks compendial changes, processes documentation change requests, and works closely with QC and Quality Assurance personnel to maintain current, consistent, and audit-ready records.
Key Responsibilities:
• Prepare, revise, and maintain analytical methods, test procedures, product specifications, and related records within controlled documentation systems.
• Monitor compendial updates from USP/NF, EP, and JP, assess their potential impact, and support the timely implementation of required document and system changes.
• Process documentation change control requests, ensuring appropriate review, accurate routing, complete supporting information, and timely closure.
• Validate, maintain, and revalidate controlled Excel spreadsheets and Empower calculations to support accuracy, traceability, and data integrity.
• Organize, label, file, archive, and retrieve paper-based and electronic QC documentation in accordance with applicable SOPs and record-retention requirements.
• Collaborate with QC analysts, supervisors, and QA reviewers to resolve documentation issues, research technical or regulatory requirements, and promote consistent documentation practices.
What We’re Looking For
Experience:
• 0-3 years of experience in a GMP-regulated pharmaceutical environment preferred.
• Previous experience with QC documentation, document control, analytical method or specification management, controlled spreadsheets, Empower, or laboratory operations strongly preferred.
Education:
• Associate’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or another related scientific discipline required.
• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or another related scientific discipline preferred. A combination of relevant education and directly related pharmaceutical QC documentation experience may be considered.
Skills & Knowledge:
• Working knowledge of cGMP, GLP, FDA expectations, Good Documentation Practices, and ALCOA+ data integrity principles.
• Familiarity with compendial sources such as USP/NF, EP, and JP and an understanding of how compendial changes may affect analytical procedures and specifications.
• Strong proficiency in Microsoft Word and Excel; experience with controlled spreadsheets, formula validation, or Empower calculations preferred.
• Exceptional attention to detail and the ability to accurately review, track, organize, and maintain technical documentation.
• Strong written and verbal communication skills, with the ability to manage multiple priorities and collaborate effectively with laboratory and quality personnel.
What We Offer
• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Professional development reimbursement
• Career growth opportunities
• Tuition reimbursement for children and childcare expense reimbursement
Schedule
• Full-time, on-site position (Monday–Friday, 8:00 AM–5:00 PM)
KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
Company DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products. Read LessAbout KVK Tech
KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
What You’ll Do
The QC Chemist III serves as a senior analytical scientist and technical resource within the Quality Control laboratory. This role independently performs and oversees advanced analytical testing, leads method validation and transfer activities, troubleshoots complex laboratory issues, reviews analytical data, and provides scientific support for investigations. The QC Chemist III also mentors less experienced chemists, strengthens laboratory practices, and supports inspection readiness while operating as a senior individual contributor without formal personnel-management responsibilities.
Key Responsibilities:
• Perform advanced and complex analytical testing of raw materials, in-process materials, finished products, and stability samples using HPLC, UPLC, GC, UV-Vis, dissolution, Karl Fischer titration, wet chemistry, and other approved analytical techniques.
• Lead or independently execute assigned analytical method validation, verification, and transfer activities, including protocol execution, data evaluation, technical documentation, and resolution of method-related issues.
• Evaluate and interpret analytical results, identify atypical data or trends, and provide scientific root-cause analysis supporting OOS/OOT investigations, deviations, CAPAs, and laboratory change controls.
• Review and approve laboratory data, calculations, chromatographic results, worksheets, logbooks, and electronic records for accuracy, completeness, scientific validity, and compliance with cGMP, ALCOA, and Data Integrity requirements.
• Qualify, calibrate, maintain, and troubleshoot laboratory instrumentation while authoring or revising associated protocols, SOPs, test methods, work instructions, and equipment records.
• Provide technical guidance, training, and mentorship to junior chemists while collaborating with QA, Manufacturing, Validation, Regulatory Affairs, and other functions to improve laboratory performance and maintain inspection readiness.
What We’re Looking For
Experience:
• Minimum of 6 years of progressively responsible analytical laboratory experience within a cGMP-regulated pharmaceutical Quality Control or closely related pharmaceutical analytical-development environment.
• Demonstrated ability to independently execute and review complex analytical testing, interpret data, troubleshoot methods and instrumentation, and apply sound scientific judgment with minimal supervision.
• Proven involvement in analytical method validation, verification, or transfer; laboratory investigations; technical-document preparation; and the training or mentorship of less experienced laboratory personnel.
Education:
• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a closely related chemistry-based scientific discipline required.
• Master’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field preferred.
Skills & Knowledge:
• Advanced proficiency with multiple analytical techniques, including HPLC, UPLC, GC, UV-Vis, dissolution, Karl Fischer titration, wet chemistry, and related pharmaceutical laboratory methods.
• Strong knowledge of analytical method validation, system suitability, chromatographic troubleshooting, scientific root-cause analysis, ICH Q2(R2), USP requirements, and applicable compendial procedures.
• Deep working knowledge of cGMP, GLP, 21 CFR Parts 11 and 211, ALCOA principles, Data Integrity expectations, OOS/OOT investigations, deviations, CAPAs, and laboratory change controls.
• Proficiency with chromatographic data systems and laboratory platforms such as Empower and LIMS, along with the ability to author protocols, technical reports, SOPs, test methods, and data summaries.
• Strong technical leadership, critical thinking, communication, organization, and mentoring skills with the ability to guide laboratory activities and cross-functional initiatives without formal supervisory authority.
What We Offer
• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Professional development reimbursement
• Career growth opportunities
• Tuition reimbursement for children and childcare expense reimbursement
Schedule
• Full-time, on-site position (Monday–Friday, 8:00 AM – 5:00 PM)
\nCompany DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
Company DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products. Read LessAbout KVK Tech
KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
What You’ll Do
The QC Chemist I/II performs analytical testing of raw materials, in-process materials, finished products, and stability samples using approved, compendial, validated, or internal test methods. This position may be filled at either QC Chemist I or QC Chemist II based on a combination of relevant professional experience, education, demonstrated technical proficiency, level of independence, instrumentation expertise, and experience with pharmaceutical Quality Control responsibilities. Placement will not be determined by years of experience or previous job title alone. QC Chemist I is intended for developing chemists capable of independently performing routine testing after qualification, while QC Chemist II is intended for experienced pharmaceutical laboratory professionals capable of handling complex testing, analytical troubleshooting, data review, investigations, and method-related activities with limited supervision.
Key Responsibilities:
• Perform analytical testing of raw materials, in-process samples, finished products, and stability samples using approved methods; Chemist I personnel primarily perform routine testing, while Chemist II personnel perform both routine and complex analyses requiring greater technical judgment.
• Operate analytical instrumentation including HPLC, UPLC, GC, UV-Vis, dissolution equipment, Karl Fischer titrators, pH meters, balances, and related laboratory equipment based on demonstrated training, qualification, and assigned level.
• Prepare and standardize samples, reference solutions, reagents, buffers, and mobile phases while documenting all laboratory activities accurately and contemporaneously in accordance with cGMP, ALCOA, and Data Integrity requirements.
• Evaluate analytical results against established specifications and acceptance criteria; Chemist I personnel identify and promptly escalate atypical or potential OOS/OOT results, while Chemist II personnel independently interpret complex data, identify trends, and review peer-generated analytical documentation.
• Support laboratory investigations, method verification, validation, transfer, and troubleshooting activities; Chemist II personnel are expected to independently execute assigned method activities, contribute to scientific root-cause analysis, and support deviations, CAPAs, and change controls.
• Perform assigned instrument calibrations, preventive maintenance, equipment readiness checks, and basic troubleshooting; Chemist II personnel also provide technical guidance to less experienced chemists and support improvements to laboratory procedures and processes.
What We’re Looking For
Experience:
• QC Chemist I: Typically requires 1–3 years of relevant professional analytical laboratory experience with a Bachelor’s degree. A candidate with a Master’s degree in Chemistry and no professional laboratory experience may also be considered for Level I based on demonstrated academic laboratory training and technical knowledge. A Bachelor’s degree without relevant professional laboratory experience will normally be considered at the QC Junior Chemist level.
• QC Chemist II: Typically requires 3–6 years of progressively responsible analytical experience in a cGMP-regulated pharmaceutical Quality Control laboratory, including demonstrated independence in analytical testing, data interpretation, instrument troubleshooting, and GMP documentation.
• Final level placement will be based on the complete qualifications of the candidate, including the relevance and quality of experience, education, independent proficiency with applicable instrumentation, complexity of testing performed, cGMP knowledge, data-review experience, investigation involvement, and method verification, validation, or transfer experience. Meeting the stated number of years alone does not guarantee Level II placement.
Education:
• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a closely related chemistry-based scientific discipline required.
• Master’s degree in Chemistry may substitute for prior professional experience when determining eligibility for QC Chemist I; an advanced degree alone does not qualify a candidate for QC Chemist II.
Skills & Knowledge:
• QC Chemist I: Ability to independently perform routine analytical testing after qualification, prepare standards and samples, complete scientific calculations, operate commonly used laboratory instruments, and produce accurate, contemporaneous GMP documentation.
• QC Chemist II: Advanced working proficiency with multiple analytical techniques such as HPLC, UPLC, GC, UV-Vis, dissolution, Karl Fischer titration, and wet chemistry, including the ability to troubleshoot instruments, interpret complex data, and review peer-generated laboratory records.
• Working knowledge of cGMP, GLP, USP requirements, ALCOA principles, Data Integrity expectations, and applicable laboratory controls; Chemist II candidates must demonstrate practical application of these requirements in a pharmaceutical QC environment.
• Experience with chromatographic data systems and laboratory documentation platforms such as Empower and LIMS, along with proficiency in Microsoft Excel, Word, and related applications.
• Strong attention to detail, scientific judgment, organization, communication, and ability to manage multiple testing assignments while maintaining laboratory safety, accuracy, and compliance.
What We Offer
• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Professional development reimbursement
• Career growth opportunities
• Tuition reimbursement for children and childcare expense reimbursement
Schedule
• Full-time, on-site position (Monday–Friday, 8:00 AM – 5:00 PM)
\nCompany DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
Company DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products. Read LessAbout KVK Tech
KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
What You’ll Do
The QC Junior Chemist supports the Quality Control laboratory by performing entry-level analytical testing, sample preparation, documentation, and laboratory support activities in accordance with approved procedures. Working under appropriate supervision, this role assists with the testing of raw materials, in-process materials, finished products, stability samples, and product development samples while developing practical proficiency in analytical techniques used within an oral solid dosage pharmaceutical manufacturing environment.
Key Responsibilities:
• Perform basic and routine analytical testing of raw materials, in-process samples, finished products, stability samples, and product development samples using approved methods and procedures.
• Prepare samples, standards, reagents, buffers, and mobile phases accurately and in accordance with approved procedures and laboratory safety requirements.
• Support wet chemistry, pH testing, titrations, loss on drying, residue testing, Karl Fischer moisture testing, UV-Vis, FT-IR, dissolution, HPLC, and other analytical techniques as assigned.
• Document all laboratory activities accurately, completely, and contemporaneously in laboratory notebooks, worksheets, logbooks, forms, and electronic systems in accordance with cGMP, ALCOA, and Data Integrity requirements.
• Verify that instruments, balances, glassware, and equipment are within calibration, qualification, and cleanliness requirements before use, and promptly report atypical results, potential OOS/OOT results, documentation discrepancies, or equipment concerns.
• Support sample handling, laboratory inventory, equipment cleaning, housekeeping, reagent labeling, waste management, and other activities necessary to maintain a safe, organized, and inspection-ready laboratory.
What We’re Looking For
Experience:
• Entry-level opportunity requiring 0–1 year of laboratory experience; relevant academic laboratory coursework, internships, or co-op experience may be considered.
• Prior experience in a pharmaceutical, cGMP, GLP, analytical, or Quality Control laboratory preferred but not required.
• Familiarity with basic laboratory safety, analytical calculations, sample preparation, and documentation practices preferred.
Education:
• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a closely related chemistry-based scientific discipline required.
• Relevant coursework in analytical chemistry, instrumental analysis, pharmaceutical sciences, or related laboratory disciplines preferred.
Skills & Knowledge:
• Foundational understanding of chemistry, laboratory practices, sample preparation, and scientific calculations, including concentrations, dilutions, standard preparations, assay calculations, and unit conversions.
• Basic familiarity with analytical techniques such as HPLC, UV-Vis, FT-IR, dissolution, Karl Fischer moisture testing, pH measurement, titration, and other wet chemistry techniques.
• Ability to follow approved procedures, test methods, specifications, and written instructions accurately and consistently while recognizing when questions or unexpected results require escalation.
• Strong attention to detail, organization, communication, and ability to produce clear, accurate, and contemporaneous laboratory documentation.
• Proficiency in Microsoft Office applications; familiarity with LIMS, Empower, or other electronic laboratory systems preferred but not required.
What We Offer
• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Professional development reimbursement
• Career growth opportunities
• Tuition reimbursement for children and childcare expense reimbursement
Schedule
• Full-time, on-site position (Monday–Friday, 8:00 AM – 5:00 PM)
\nCompany DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
Company DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products. Read LessAccounts Payable Specialist
About KVK Tech
KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
What You’ll Do
The Accounts Payable Specialist is responsible for managing the full accounts payable cycle, ensuring timely, accurate, and compliant processing of vendor invoices and payments. This role plays a critical part in maintaining strong financial controls, supporting vendor relationships, and ensuring accounting accuracy within a regulated pharmaceutical manufacturing environment.
Key Responsibilities:
Process vendor invoices and payment requests, ensuring accuracy, proper approvals, and correct general ledger coding.Perform invoice matching activities (2-way and 3-way matching, as applicable) and resolve discrepancies related to pricing, quantities, or documentation.Prepare and execute weekly and ad hoc payment runs, including ACH, check, and wire payments.Maintain and update vendor records, including payment terms, remit-to information, banking details, and tax documentation.Respond to vendor inquiries and statements; research and resolve aged or disputed items in a timely and professional manner.Monitor accounts payable aging and payment terms to support uninterrupted supply and services.Support month-end close activities related to accounts payable, including documentation and AP schedules as assigned.Maintain organized, audit-ready records supporting invoice approval, payment, and posting activities.Identify opportunities to improve accounts payable processes, efficiency, and internal controls.
What We’re Looking For
Experience:
0–3 years of hands-on accounts payable experience in a professional accounting environment.Experience in a manufacturing, distribution, or regulated environment strongly preferred (pharmaceutical experience is a plus).Demonstrated experience working with invoice approvals, payment processing, and internal control procedures.
Education:
Associate’s degree in Accounting, Finance, Business Administration, or a related field preferred.Equivalent combination of education and relevant experience will be considered.
Skills & Knowledge:
Strong working knowledge of accounts payable fundamentals, including invoice processing, matching, payment terms, and vendor maintenance.Experience using accounting or ERP systems and electronic invoice workflows.Proficiency in Microsoft Excel and Microsoft Outlook; comfortable working with detailed financial data.High attention to detail with strong organizational and time-management skills.Clear written and verbal communication skills for interaction with vendors and internal stakeholders.Ability to handle sensitive financial information with discretion and professionalism.
What We Offer
Competitive base salaryAnnual merit-based pay increasesAutomatic enrollment in a 401(k) at 3% pre-tax with a 50% company match on the first 6% contributedPaid Time Off10 paid company holidaysComprehensive medical, dental, vision, and life insurance coverageProfessional development reimbursementCareer growth opportunitiesTuition reimbursement for children and childcare expense reimbursement
Schedule
Full-time, on-site position (M-F 8:00 AM - 5:00 PM)\nCompany DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
Company DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products. Read LessAbout KVK Tech
KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
What You’ll Do
The Assistant Manager, Packaging supports the Packaging Manager in leading the daily operations of the Packaging Department within a regulated oral solid dosage pharmaceutical manufacturing environment. This role provides operational leadership across packaging shifts, lines, and personnel to ensure production schedules are achieved safely, efficiently, and in compliance with cGMP, FDA, DEA, OSHA, and company requirements. The Assistant Manager coordinates closely with Packaging Supervisors and cross-functional departments, supports employee development and performance management, and serves as a designated departmental leader in the Packaging Manager’s absence.
Key Responsibilities:
• Support the Packaging Manager in overseeing daily packaging operations and ensuring compliance with approved procedures, cGMP requirements, safety standards, and production expectations.
• Provide leadership and direction to Packaging Supervisors and other packaging personnel across assigned shifts, lines, or operational areas.
• Coordinate daily and weekly packaging schedules, staffing assignments, material readiness, equipment availability, and production priorities.
• Monitor packaging line performance, schedule attainment, labor utilization, downtime, waste, and other departmental performance indicators.
• Review packaging batch records, logbooks, reconciliation records, cleaning documentation, and production reports for accuracy, completeness, and timely completion.
• Collaborate with Quality Assurance, Manufacturing, Warehouse, Shipping, Engineering, Maintenance, and other departments to resolve issues and maintain production flow.
• Support packaging-related deviations, investigations, CAPAs, change controls, root cause analyses, and other Quality System activities.
• Identify recurring production issues and implement or recommend process improvements to increase efficiency, reduce downtime, and minimize waste.
• Coach and develop Packaging Supervisors, Line Leaders, Operators, Material Handlers, and Mechanics to strengthen performance, accountability, technical capability, and compliance.
• Ensure packaging personnel receive required training on SOPs, cGMP, ALCOA+, data integrity, safety procedures, equipment operation, and departmental expectations.
• Assist with employee performance management, attendance concerns, coaching, corrective actions, and staffing recommendations in coordination with the Packaging Manager and Human Resources.
• Support new product introductions, packaging line trials, equipment qualifications, process validations, and continuous improvement initiatives.
• Ensure packaging information is entered accurately and timely into ERP and production reporting systems.
• Prepare and communicate production updates, performance metrics, staffing concerns, operational risks, and departmental priorities to management.
• Support internal audits and regulatory inspections by maintaining inspection readiness and assisting with document retrieval and operational walkthroughs.
• Serve as the designated departmental leader in the absence of the Packaging Manager within assigned authority.
What We’re Looking For
Experience:
• Minimum of 6–9 years of progressive experience in pharmaceutical packaging, pharmaceutical manufacturing, or another cGMP-regulated production environment.
• Minimum of 2–3 years of leadership, supervisory, or management experience overseeing production employees, packaging lines, or manufacturing operations.
• Demonstrated experience coordinating production schedules, staffing, equipment availability, material readiness, and cross-functional operational support.
• Experience reviewing batch records, reconciliation records, production documentation, and packaging performance data.
• Experience supporting deviations, investigations, CAPAs, change controls, equipment qualifications, or continuous improvement activities preferred.
• Experience coaching supervisors, developing production employees, and addressing performance or compliance concerns.
• Experience within oral solid dosage pharmaceutical packaging strongly preferred.
Education:
• High school diploma or equivalent required.
• Bachelor’s degree in Business Administration, Operations Management, Engineering, Pharmaceutical Sciences, or a related field preferred.
• An equivalent combination of education, technical training, and relevant pharmaceutical packaging experience may be considered.
Skills & Knowledge:
• Strong working knowledge of pharmaceutical packaging operations, cGMP requirements, Good Documentation Practices, ALCOA+, and data integrity standards.
• Strong leadership, coaching, and team-development skills with the ability to provide direction across multiple packaging lines and shifts.
• Knowledge of packaging equipment operation, line setup, changeovers, reconciliation, line clearance, and operator-level troubleshooting.
• Ability to review batch records, logbooks, cleaning records, reconciliation documentation, and production reports.
• Working knowledge of deviations, investigations, CAPAs, change controls, root cause analysis, and other pharmaceutical Quality System processes.
• Familiarity with equipment qualification and packaging process validation activities, including IQ, OQ, and PQ.
• Ability to analyze production data, identify performance trends, investigate operational losses, and implement sustainable improvements.
• Proficiency with ERP or production reporting systems such as SYSPRO, SAP, JDE, or equivalent.
• Proficiency with Microsoft Office applications, including Excel, Word, Outlook, and PowerPoint.
• Strong critical-thinking, problem-solving, organizational, and decision-making abilities.
• Excellent written and verbal communication skills for interaction with employees, management, and cross-functional departments.
• Ability to manage multiple priorities, respond to changing production requirements, and make timely operational decisions.
What We Offer
• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Professional development reimbursement
• Career growth opportunities
• Tuition reimbursement for children and childcare expense reimbursement
Schedule
• Full-time, on-site position, (primarily Monday–Friday, 9:00 AM-6:00 PM) with flexibility required to support packaging operations across multiple shifts, including occasional evenings, weekends, or extended hours based on business needs.
\nCompany DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
Company DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products. Read LessAbout KVK Tech
KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
What You’ll Do
The Packaging Supervisor is responsible for overseeing daily packaging operations to ensure safe, efficient, and compliant execution of production activities within a regulated pharmaceutical manufacturing environment. This role leads packaging personnel, supports schedule attainment, enforces cGMP and safety requirements, and ensures packaging documentation is accurate, complete, and audit-ready. The Packaging Supervisor partners closely with Quality, Warehouse, Manufacturing, Shipping, and other cross-functional teams to maintain operational continuity, minimize downtime, and drive performance across the packaging area.
Key Responsibilities:
• Supervise daily packaging line operations to ensure production activities are executed safely, efficiently, and in compliance with cGMP, FDA, DEA, OSHA, and company requirements.
• Plan, assign, and adjust shift activities to support production schedules, staffing needs, and operational priorities.
• Monitor packaging processes and floor activity to ensure adherence to SOPs, line clearance requirements, housekeeping standards, and approved procedures.
• Review packaging documentation including batch records, logbooks, cleaning records, and production forms for accuracy, completeness, and timeliness.
• Coordinate with Quality Assurance, Warehouse, Manufacturing, Shipping, and other departments to resolve issues affecting material availability, packaging flow, and schedule execution.
• Train, coach, and develop Packaging Line Leaders, Operators, Material Handlers, and Mechanics to strengthen team performance, compliance, and technical capability.
• Track productivity, downtime, and operational performance trends and recommend improvements to increase efficiency and reduce waste.
• Ensure production data and transaction reporting are entered accurately into ERP systems such as SYSPRO and maintained in accordance with company and regulatory requirements.
• Prepare and communicate shift updates, performance summaries, and operational concerns to management.
• Support investigations, continuous improvement initiatives, and departmental projects as assigned.
What We’re Looking For
Experience:
• Minimum of 5–8 years of relevant experience in a pharmaceutical, food, or other regulated manufacturing environment.
• At least 2 years of leadership, lead, or supervisory experience overseeing production or packaging personnel.
• Demonstrated knowledge of cGMP requirements, data integrity principles, and packaging documentation practices.
• Experience using ERP or inventory systems such as SYSPRO, SAP, JDE, or similar platforms preferred.
• Proven experience training, coaching, and coordinating the work of operations staff in a fast-paced production setting.
Education:
• High school diploma or equivalent required.
• College degree or technical school certification preferred; equivalent relevant experience may be considered in lieu of additional education.
Skills & Knowledge:
• Strong leadership skills with the ability to motivate, coach, and hold teams accountable for safety, quality, and performance.
• Working knowledge of packaging operations, production flow, and operator-level equipment oversight.
• Proficiency in packaging documentation review, production reporting, and compliance with data integrity requirements.
• Ability to analyze operational issues, monitor performance trends, and support process improvements.
• Strong written and verbal communication skills with the ability to interact effectively across departments and leadership levels.
• Ability to prioritize competing demands, manage multiple activities simultaneously, and adapt to changing production schedules.
• Solid understanding of regulatory expectations including cGMP, FDA, DEA, OSHA, and EPA requirements.
What We Offer
• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Professional development reimbursement
• Career growth opportunities
• Tuition reimbursement for children and childcare expense reimbursement
Schedule
• Full-time, on-site position (Monday–Friday, 3:30 PM-12:00 AM)
\nCompany DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
Company DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products. Read Less