System One
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 #LI-MM1
Ref: #558-Scientific
#J-18808-Ljbffr
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 #LI-MM1
Ref: #558-Scientific
#J-18808-Ljbffr