Pharma Universe
The Quality Control Analyst II performs analytical testing and data verification to support late-stage clinical and commercial biosimilar products in cGMP-compliant laboratories. This role also contributes to continuous improvement initiatives to enhance Quality Systems efficiency and effectiveness.
Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding.
Key Responsibilities
Conduct in-process, release, and stability testing using techniques such as HPLC, SDS-PAGE, ELISA, bioassays, and compendial methods Troubleshoot analytical results and ensure compliance with cGMP, ICH guidelines, and Quality Systems Perform and review OOS investigations, deviations, and CAPAs Collaborate with cross-functional teams on projects, documentation, and equipment maintenance Train analysts and participate in internal audits and assessments Adhere to all company policies and regulatory standards
Experience/Qualifications
Bachelor's degree in biotechnology, biochemistry, chemistry, or related field with 5+ years of QC experience in a pharmaceutical/biotech lab; or Strong background in protein chemistry and experience working in a cGMP laboratory Proven ability to write, revise, and follow SOPs, protocols, and QC methods Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionQuality Assurance IndustriesIT Services and IT Consulting Referrals increase your chances of interviewing at Pharma Universe by 2x Sign in to set job alerts for “Quality Control Analyst” roles. Piscataway, NJ $40,000.00-$300,000.00 3 months ago Piscataway, NJ $80,000.00-$120,000.00 2 weeks ago Rahway, NJ $85,600.00-$134,800.00 3 days ago Rahway, NJ $85,600.00-$134,800.00 4 hours ago Quality Assurance Specialist-Pharmaceutical Cranbury, NJ $294,000.00-$352,666.00 1 week ago Morris Plains, NJ $85,400.00-$158,600.00 2 weeks ago Millburn, NJ $81,200.00-$150,800.00 1 week ago Millburn, NJ $81,200.00-$150,800.00 2 weeks ago Millburn, NJ $81,200.00-$150,800.00 4 days ago Morris Plains, NJ $103,500.00-$192,400.00 4 days ago Analytical Lab Technician - Piscataway, NJQuality Assurance Specialist (QAS) - Pharmaceutical CGMP Raritan, NJ $69,500.00-$102,350.00 6 days ago Cranbury, NJ $68,000.00-$81,333.00 2 weeks ago Raritan, NJ $69,500.00-$102,350.00 1 week ago Quality Assurance in Veterinary Diagnostics/Medical Devices || Onsite RoleLab Materials and Records Specialist and Patch Preparation TechnicianSenior Associate Scientist- Quality Control Cranbury, NJ $82,000.00-$98,000.00 1 week ago Quality Assurance And Regulatory Affairs Specialist We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding.
Key Responsibilities
Conduct in-process, release, and stability testing using techniques such as HPLC, SDS-PAGE, ELISA, bioassays, and compendial methods Troubleshoot analytical results and ensure compliance with cGMP, ICH guidelines, and Quality Systems Perform and review OOS investigations, deviations, and CAPAs Collaborate with cross-functional teams on projects, documentation, and equipment maintenance Train analysts and participate in internal audits and assessments Adhere to all company policies and regulatory standards
Experience/Qualifications
Bachelor's degree in biotechnology, biochemistry, chemistry, or related field with 5+ years of QC experience in a pharmaceutical/biotech lab; or Strong background in protein chemistry and experience working in a cGMP laboratory Proven ability to write, revise, and follow SOPs, protocols, and QC methods Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionQuality Assurance IndustriesIT Services and IT Consulting Referrals increase your chances of interviewing at Pharma Universe by 2x Sign in to set job alerts for “Quality Control Analyst” roles. Piscataway, NJ $40,000.00-$300,000.00 3 months ago Piscataway, NJ $80,000.00-$120,000.00 2 weeks ago Rahway, NJ $85,600.00-$134,800.00 3 days ago Rahway, NJ $85,600.00-$134,800.00 4 hours ago Quality Assurance Specialist-Pharmaceutical Cranbury, NJ $294,000.00-$352,666.00 1 week ago Morris Plains, NJ $85,400.00-$158,600.00 2 weeks ago Millburn, NJ $81,200.00-$150,800.00 1 week ago Millburn, NJ $81,200.00-$150,800.00 2 weeks ago Millburn, NJ $81,200.00-$150,800.00 4 days ago Morris Plains, NJ $103,500.00-$192,400.00 4 days ago Analytical Lab Technician - Piscataway, NJQuality Assurance Specialist (QAS) - Pharmaceutical CGMP Raritan, NJ $69,500.00-$102,350.00 6 days ago Cranbury, NJ $68,000.00-$81,333.00 2 weeks ago Raritan, NJ $69,500.00-$102,350.00 1 week ago Quality Assurance in Veterinary Diagnostics/Medical Devices || Onsite RoleLab Materials and Records Specialist and Patch Preparation TechnicianSenior Associate Scientist- Quality Control Cranbury, NJ $82,000.00-$98,000.00 1 week ago Quality Assurance And Regulatory Affairs Specialist We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr