New · posted Nov 10
Amneal Pharmaceuticals · Pharmaceuticals
Associate Scientist, Quality Control
- Piscataway, NJ
- On-site
- Full-time
- Associate & Specialist
The role
The Scientist I - QC is an entry-level role responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, to clearly document activities performed during testing and to calculate and report results on applicable specification documents.
What you need
Education
- Bachelors Degree (BA/BS) Chemistry or related field - Required
Experience
- less than one year in Testing of chemicals/pharmaceutical products
- 1 year or more in Testing of chemicals/pharmaceutical products
Specialized Knowledge
- Must possess a working knowledge of analytical chemistry techniques, such as analytical weighing, quantitative transfer, preparation of quantitative solutions, analytical dilutions, spectrophotometric analytical techniques, dissolution and drug release, disintegration, moisture determination (Karl Fischer, Coulometric, LOD), thin-layer chromatographic technique, gas chromatographic techniques, HPLC, and measuring physical parameters (bulk and tapped densities, and particle size by sieve analysis).
- Must be able to follow compendial (USP/EP/BP/JP) procedures for wet chemical tests.
- Must understand and apply cGMP requirements applicable to quality control laboratory.
The base salary for this position ranges from $65,000 to $80,000 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
- Performs physical and chemical analysis of raw materials, in-process and finished pharmaceutical products, including products on stability, according to written methods or compendial methods as applicable, material specifications, using analytical techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatographic techniques adhering to company policies as identified in standard operating procedures (SOPs).
- Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using chromatographic techniques and other analytical techniques as applicable.
- Creates and maintains laboratory record documentation (notebooks and computer-based), documents exact steps followed during analysis execution, calculates and reports results in a timely manner.
- Actively participates in investigation of laboratory results, when required.
- Assists, as and when needed, scientists working in the laboratory.
- Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.
- Performs calibration of dissolution apparatus, FT-IR, UV-Vis spectrophotometer, HPLC as assigned by the supervisor.
- Prepares volumetric test solutions following USP or in-house methods for wet chemical tests, standardizes such solutions as required, standardizes API for use as in-house reference standard as assigned.
Pay and benefits
$65,000 – $80,000 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 · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Quality Control roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US85 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $65,000 | — | $80,000 |
| All US (middle half) | $64,000 | $72,500 | $88,500 |
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, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 256 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 16 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods14
- Documentation and SOPs4
- GMP and compliance1
- Investigations and CAPA1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Control work in pharmaceuticals, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validationNamed in the posting
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ICHICH Q1 stability testing(official source, opens in a new tab)Stability testing of drug substances and drug products
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratories
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- ICHICH Q3 impurities(official source, opens in a new tab)Impurities in drug substances and products, residual solvents and elemental impurities
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
Company hiring pulse
Amneal on Regulatory Jobs
- 21
- Open roles
- 21
- Distinct roles
- 3
- Locations
By discipline
- Quality21 95%
- Clinical1 5%
By level
- Associate & Specialist9 41%
- Senior & Principal7 32%
- Director4 18%
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Associate Scientist, Quality Control at Amneal
Open until filled. $65K–$80K a year, employer provided.