Quality Control Analyst II/III

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) Ref: