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)

  
  
  
  
  
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  Ref: #558-Scientific