Associate Manager, Quality Control

Amneal • Piscataway, NJ

22d • $80,000 - $110,000

About The Position

The Associate Manager, Quality Control prepares testing schedules based on priorities, provides hands-on training to new hires, supervises daily testing activities to ensure adherence to laboratory procedures, cGMP, and SOPs, conducts laboratory investigations as needed, and participates in cross-functional teams to understand priorities and deliver on commitments.

The role oversees testing and review of raw materials, in-process and finished products, stability and complaint samples, and samples related to process and cleaning validation. It supports timely testing and release, laboratory compliance and data integrity, analytical investigations, controlled-document updates, method changes, records review, staff training, and sample delivery tracking.

Requirements

• Bachelor's degree in Chemistry or a related technical field.
• At least 7 years of pharmaceutical laboratory experience with a bachelor's degree, or at least 5 years with a master's degree.
• At least 2 years of supervisory experience.
• In-depth knowledge of analytical chemistry techniques, including spectrophotometric, dissolution and drug-release, chromatographic, and physical-parameter measurement techniques.
• Ability to follow compendial USP, EP, BP, and JP analytical procedures.
• Understanding of cGMP requirements applicable to a quality control laboratory.
• 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; provide written assignments one day in advance.
• Supervise laboratory work in real time and enforce data integrity, SOP, specification, method, USP, and cGMP requirements through record and instrument-output verification.
• Troubleshoot analytical methods, instrumentation, and test execution with analysts.
• Initiate and participate in OOS/OOAL investigations, prepare investigation reports and other required reports, close investigations after approval, and ensure timely completion and implementation of CAPAs.
• 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 compendial method changes relevant to products and notify management so that an appropriate course of action can be determined.
• 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 and 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 and summarize in-process, finished-product release, and stability data for trending when required.
• Attend production planning meetings, update committed delivery dates, track performance against commitments, and submit weekly lists of samples received and completed.

Benefits

• Above-market health and insurance benefits, with plan and coverage choices for eligible positions.
• Significant 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

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