Associate Manager, Quality Control

Amneal

21d

About The Position

The Associate Manager, Quality Control schedules and oversees laboratory testing to ensure adherence to procedures, cGMP, SOPs, and applicable requirements. The role provides hands-on training, supports analysts with troubleshooting, conducts and participates in laboratory investigations, and works with cross-functional teams to meet priorities and committed delivery dates.

The position oversees testing and review of raw materials, in-process and finished products, stability and complaint samples, and samples associated with process and cleaning validation. It also reviews and approves analytical records and reports, supports method transfers and validation activities, ensures implementation of CAPAs, manages laboratory document changes, and monitors analytical data for trends. The role participates in laboratory testing and special projects as needed and provides updates on sample flow and delivery commitments.

Candidates must meet the stated education and experience requirements and have in-depth knowledge of analytical chemistry techniques, compendial procedures, and cGMP requirements for a quality control laboratory. The base salary ranges from $80,000 to $110,000 per year. Eligible positions include a flexible benefits program with health and insurance benefits, a 401(k) matching contribution, and employee well-being programs.

Requirements

• Bachelor’s degree in chemistry or a related technical field, required.
• For candidates with a bachelor’s degree: at least 7 years of pharmaceutical laboratory experience and at least 2 years of supervisory experience.
• For candidates with a master’s degree: at least 5 years of pharmaceutical laboratory experience and at least 2 years of supervisory experience.
• In-depth knowledge of analytical chemistry techniques, including spectrophotometric, dissolution and drug-release, chromatographic (standalone or hyphenated), and physical-parameter measurement techniques such as viscosity, laser-diffraction particle or droplet size, and DSC melting-point analysis.
• Ability to follow compendial USP, EP, BP, and JP analytical procedures.
• Understanding and application of cGMP requirements applicable to quality control laboratories.
• Ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and promptly, and report actions to laboratory management in a timely manner.
• Ability to identify trends in analytical data.

Nice To Haves

• Master’s degree in chemistry or a related technical field.

Responsibilities

• Schedule testing and review of raw-material, in-process, finished-product, stability, complaint, process-validation, and cleaning-validation samples, with written assignments provided a day in advance.
• Supervise daily laboratory activities and enforce compliance with data integrity requirements, SOPs, specifications, methods, USP, and cGMP through real-time record and laboratory checks.
• Troubleshoot analytical methods, instrumentation, and test execution to support analysts.
• Initiate and participate in OOS/OOAL investigations, prepare investigation reports, and close investigations in the books in a timely manner once approved.
• Prepare method-transfer, method-verification, and method-validation reports where required.
• Ensure implementation of CAPAs identified during investigations.
• Ensure timely laboratory testing and release of raw materials, in-process materials, finished products, and stability samples.
• Review and approve COAs, stability summary reports, investigations, APR trend data, calibrations, qualifications, and other analytical records as needed.
• Initiate change controls for revisions to controlled laboratory documents, including SOPs, methods, stability protocols, and specifications.
• Review changes to compendial methods for applicable products and notify management to determine an appropriate course of action.
• Ensure laboratory personnel complete weekly worksheets, review them against schedules, and submit completed worksheets.
• Participate in day-to-day laboratory testing and assist analysts as needed.
• Review method-transfer protocols, reports, vendor qualification reports, USP monograph evaluation reports, and training records.
• Identify analysts’ training needs and provide training as needed.
• Participate in analysis for special projects when required.
• Summarize in-process testing, finished-product testing and release, and stability data for trending when required.
• Attend production planning meetings, update committed delivery dates, and track delivery against commitments.
• Submit a weekly list of samples received and completed.

Benefits

• Above-market health and insurance benefits for eligible positions.
• Significant 401(k) matching contribution.
• Employee well-being programs.
• Flexible benefits program allowing eligible employees to choose plans and coverage to meet their needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager