New · posted Oct 15
Amneal Pharmaceuticals · Pharmaceuticals
Associate Manager, Quality Control
- Piscataway, NJ
- On-site
- Full-time
- Manager
Open until filled
The role
This role prepares testing schedules based on priorities, provides hands-on training to new hires, supervises daily testing activities to assure adherence to procedures, cGMP, and SOPs applicable to laboratories, conducts laboratory investigations when needed, participates in cross-functional teams to understand priorities, commits and delivers as committed.
What you need
Two ways to qualify
Bachelor’s
+ 7+ years of experience
Bachelor's Degree with 7 years or more in Pharmaceutical Laboratory experience and 2 years or more in Supervisory experience.
- or
Master’s
+ 5+ years of experience
Master's Degree with 5 years or more in Pharmaceutical Laboratory experience and 2 years or more in Supervisory experience.
Education
- Bachelor's Degree (BA/BS) Chemistry or related technical field - Required
- Master's degree (MS/MA) Chemistry or related technical field - Preferred
Experience
Specialized Knowledge
- Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hypenated) and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC).Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis.Must understand and apply cGMP requirements applicable to quality control laboratory.Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner and report actions to the laboratory management in a timely manner.Must be able to identify trends in analytical data.
The base salary for this position ranges from $80,000 to $110,000 per year. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities.
What you'll do
- Schedules testing/review of raw materials, in-process, finished product, and stability samples, complaint samples, samples from process and cleaning validation activities; assignments shall be in writing and a day in advance.
- Drives effective and efficient shop floor supervision enforcing compliance to data integrity, SOPs, specifications, methods, USP, and cGMP through real time verifications of records, LNB, log book, chromatograms, sequences, etc. Helps analysts by trouble shooting methods, instrumentation and execution of the tests.
- Initiates OOS/OOAL investigation, participates in investigation activities, and closes in the books when approved, in a timely manner. Prepares reports of investigation, method transfers, method verification/validation where required. Ensures implementation of CAPA, as identified during the investigations.
- Ensures timely testing and releases of raw materials, in-process, finished products, stability samples from the lab. Reviews and approves, COA, stability summary reports, investigations, APR trend data, calibrations, qualifications, and other analytical records as needed.
- Initiates change controls for revisions to any controlled document (SOPs, methods, stability protocol,and specification) applicable to quality laboratory.
- Reviews changes in compendial methods for applicable products and notifies management of such changes in order to determine appropriate course of action.
- Has all laboratory personnel complete weekly worksheet, reviews worksheets with respect to schedules, and submits completed worksheets. Involved in day-to-day laboratory testing and helps analysts as and when needed.
- Reviews method transfer protocols/reports/vendor qualifications reports/USP monograph evaluation reports/training records. Identifies training needs and provides necessary training to the analysts as and when needed.
- Participates in analysis as and when required for special projects. When required, summarizes data for in-process testing, testing and release of finished products, and stability data for trending.
- Attends production planning meeting and updates list with delivery dates committed, track delivery dates with respect to committed dates. Submits a list containing weekly samples-in and out.
Pay and benefits
$80,000 – $110,000 a year
Employer providedHealth and insurance benefits
401(k) matching contribution
Employee well-being programs
Where you'll work
Piscataway, NJOn-siteOpen in Maps (opens in a new tab)
More jobs in Piscataway, NJJob intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 25% below the US median for Quality Control roles at this level.
This roleEmployer provided
Manager roles in the US24 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $80,000 | — | $110,000 |
| All US (middle half) | $108,500 | $127,250 | $143,500 |
This role: Amneal Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 275 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Amneal's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 17 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods14
- Documentation and SOPs8
- Investigations and CAPA4
- GMP and compliance3
- Validation and qualification3
- Collaboration and leadership3
- Quality systems and risk1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- USPUSP compendial chapters(official source, opens in a new tab)Bioburden (USP <61>), endotoxin (USP <85>), TOC (USP <643>) and water testing
Company hiring pulse
Amneal on Regulatory Jobs
- 14
- Open roles
- 10
- Distinct roles
- 2
- Locations
By discipline
- Quality14 100%
By level
- Senior & Principal7 50%
- Associate & Specialist4 29%
- Manager2 14%
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Associate Manager, Quality Control at Amneal
Open until filled. $80K–$110K a year, employer provided.