Quality Control Analyst II/III

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Joulé
Piscataway, NJ, United States
75000 - 82000 USD / Year
  • Environmental
  • Weekdays
  • Applications have closed

Job Title: Quality Control Analyst II/III

Location: Piscataway, NJ (onsite: some travel to South Plainfield)

Hours/Schedule: Monday-Friday, 8:30AM-5:00PM (with occasional early/late hours once per month during production runs)

Type: Direct Hire

Compensation: $75,000-$82,000 (based on experience)

Overview
Join a growing biopharmaceutical company that is expanding its Quality Control operations! This is a unique opportunity to advance your career in a collaborative, cutting-edge environment where you’ll work with both late-stage clinical and commercial small molecule and biosimilar products. Candidates must bring strong GMP and regulatory knowledge, with expertise in protein chemistry and analytical troubleshooting. If you enjoy problem-solving, hands-on testing, and contributing to life-changing therapies, this role is for you.

Responsibilities

  • Execute analytical testing for in-process, raw material, release, and stability samples

  • Perform and troubleshoot methods including HPLC (Empower), SDS-PAGE, cell-based bioassays, ELISA, capillary electrophoresis, and compendial assays

  • Document results in compliance with GMP, ICH, and FDA standards

  • Author and revise SOPs, QC methods, technical reports, and investigation summaries

  • Support batch release, batch record reviews, and regulatory dossier preparation

  • Lead and/or support laboratory investigations, deviations, OOS results, and CAPAs

  • Participate in Quality Events and regulatory inspections (e.g., PAI)

  • Collaborate with cross-functional teams to ensure laboratory readiness and continuous improvement

Requirements

  • Bachelor’s in Biotechnology, Biochemistry, Chemistry, or related field with 3-10 years QC experience, depending on level:

  • Level II: 6 years (Bachelor’s) or 3-4 years (Master’s)

  • Level III: 10 years (Bachelor’s) or 8 years (Master’s)

  • Previous cGMP laboratory experience – required

  • Strong Quality Control experience in a manufacturing environment

  • Demonstrated expertise in small molecule and protein chemistry

  • Proficiency with HPLC (Empower), SDS-PAGE, ELISA, bioassays, and compendial assays

  • Ability to troubleshoot analytical data and interpret/report results accurately

  • Prior experience supporting regulatory inspections and preparing data packages/dossiers

  • Strong technical writing & documentation skills (SOPs, QC methods, reports)

M3

Ref: #558-Scientific

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