A
Full Time Permanent

New Brunswick, New Jersey · USA job

Senior Scientist, Quality Control

Amneal Pharmaceuticals

New Brunswick, New Jersey

Job description

Overview

In this QC role you will perform physical and chemical analyses of materials and products, ensure specification compliance, and support validation and investigations. You will collaborate with cross-functional teams to promote compliance and continuous improvement. You will leverage advanced analytical techniques to generate reliable data and report findings, contributing to product quality and regulatory readiness. This position offers scope to influence lab processes and training within a quality-driven environment.

Compensation / Benefits
  • short-term incentive opportunity
  • competitive base salary
  • full-time position
Responsibilities
  • Perform analytical testing of raw materials, in-process, finished products, and stability samples according to SOPs and specifications
  • Conduct process and cleaning validation/verification testing and assist with method transfer across facilities
  • Calibrate and operate analytical instruments (HPLC, UV-Vis, dissolution, Karl Fischer, pH meters, IR, TLC) and document results
  • Review data for completeness and compliance, report abnormalities to supervision, and investigate results
  • Participate in non-routine projects including out-of-specification investigations and out-of-alert investigations
  • Assist with training of junior technicians/scientists and support instrument/software troubleshooting
  • Ensure expired chemicals and reference standards are removed from the laboratory
Key requirements
  • 5+ years in a Bachelors degree role focusing on testing of chemicals/pharmaceutical products
  • 3+ years in a Masters degree role focusing on testing of chemicals/pharmaceutical products
  • In-depth knowledge of analytical chemistry techniques (spectrophotometric, dissolution/drug release, chromatographic techniques) and physical parameter measurements
  • Experience following compendial procedures (USP/EP/BP/JP) and applying cGMP requirements in QC
  • Ability to troubleshoot analytical and instrument-related problems and report actions to management
  • Ability to identify trends in analytical data
  • problem-solving
  • attention to detail
  • effective communication
  • HPLC with UV detection
  • Dissolution testing
  • UV-Vis spectrophotometry

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