Manager, QC Lab
Amneal Pharmaceuticals
July 01, 2026
On-site
Piscataway, NJ
Operations
Manager, QC Lab
Responsibilities:
- Manage the Quality Control laboratory day-to-day, set/communicate priorities based on production schedule, and ensure timely testing for production material use and finished product release.
- Ensure stability samples are tested within timelines in relevant SOPs; maintain laboratory activities aligned with compliance expectations.
- Enforce and maintain laboratory GMP systems; update SOPs/policies; interpret SOPs/methods/specifications and provide clarity.
- Investigate out-of-specification (OOS) laboratory results; ensure investigations are logical, orderly, timely; identify CAPA; review/approve investigation reports.
- Review/sign off: process validation/cleaning validation protocols/reports, method verification/validation reports, annual product review reports.
- Review certificates of analysis for specification compliance.
- Develop systems to improve GMP compliance and/or productivity; implement solutions for deficiencies.
- Provide performance feedback to staff (including disciplinary action when necessary); provide input on headcount/turnover, employee development, promotions and salary increases; research/propose capital projects.
Qualifications:
- Skills in analytical testing: spectrophotometry; chromatographic techniques (HPLC/GC) and data acquisition software; dissolution/dissolution profiles/drug release; disintegration; moisture determination (Karl Fischer, Coulometric, LOD).
- Ability to understand/execute compendial procedures (USP/BP/EP/JP); troubleshoot instrument/procedure issues.
- Strong planning/organization for complex, multiple tasks; cross-functional teamwork.
- Understand and apply cGMP for pharmaceutical quality control; resolve conflicts within/between departments.
Education & Experience:
- Bachelor’s degree in Pharmacy or Chemistry or Pharmaceutical Manufacturing.
- 12 months’ experience in the position or related position.
Salary/Location:
- $137K–$140K per annum. Hours: 40 hrs/wk (8:30am–5:30pm). Piscataway, NJ.
- Ref # 12458
Responsibilities:
- Manage the Quality Control laboratory day-to-day, set/communicate priorities based on production schedule, and ensure timely testing for production material use and finished product release.
- Ensure stability samples are tested within timelines in relevant SOPs; maintain laboratory activities aligned with compliance expectations.
- Enforce and maintain laboratory GMP systems; update SOPs/policies; interpret SOPs/methods/specifications and provide clarity.
- Investigate out-of-specification (OOS) laboratory results; ensure investigations are logical, orderly, timely; identify CAPA; review/approve investigation reports.
- Review/sign off: process validation/cleaning validation protocols/reports, method verification/validation reports, annual product review reports.
- Review certificates of analysis for specification compliance.
- Develop systems to improve GMP compliance and/or productivity; implement solutions for deficiencies.
- Provide performance feedback to staff (including disciplinary action when necessary); provide input on headcount/turnover, employee development, promotions and salary increases; research/propose capital projects.
Qualifications:
- Skills in analytical testing: spectrophotometry; chromatographic techniques (HPLC/GC) and data acquisition software; dissolution/dissolution profiles/drug release; disintegration; moisture determination (Karl Fischer, Coulometric, LOD).
- Ability to understand/execute compendial procedures (USP/BP/EP/JP); troubleshoot instrument/procedure issues.
- Strong planning/organization for complex, multiple tasks; cross-functional teamwork.
- Understand and apply cGMP for pharmaceutical quality control; resolve conflicts within/between departments.
Education & Experience:
- Bachelor’s degree in Pharmacy or Chemistry or Pharmaceutical Manufacturing.
- 12 months’ experience in the position or related position.
Salary/Location:
- $137K–$140K per annum. Hours: 40 hrs/wk (8:30am–5:30pm). Piscataway, NJ.
- Ref # 12458