Quality Control Analyst

This established pharmaceutical company that is focused on developing innovative biologic therapies is seeking a QC Analyst to support GMP manufacturing and product release activities. Due to continued growth of the biologics pipeline, they are expanding the QC organization to add experienced capillary electrophoresis expertise.

The QC Analyst will report into the Director of Quality Control and support a growing QC group.

• Bachelor’s degree or higher in Chemistry, Biochemistry, Biotechnology, or related discipline with 4+ years of QC experience in an FDA-regulated biotech or pharmaceutical environment
• Hands-on experience with capillary electrophoresis assays including CE-SDS (reduced and non-reduced), Capillary Zone Electrophoresis (CZE), and imaged capillary isoelectric focusing (icIEF)
• Experience working under cGMP and EU GMP regulations with familiarity with USP and EP requirements
• Working knowledge of additional analytical techniques such as HPLC, GC, and TOC, and chromatography data systems (e.g., Empower)
• Strong analytical, problem-solving, and communication skills in a fast-paced QC environment

• Perform routine and non-routine testing using CE-SDS (R/), CZE, and icIEF to support in-process, release, and stability testing of biologic products
• Review, interpret, and report GMP-compliant analytical data for assigned assays
• Troubleshoot CE assays and instrumentation and lead laboratory investigations (OOS, OOT, deviations, CAPAs)
• Support method transfer and validation for CE-based assays and maintain qualified laboratory equipment
• Author and maintain SOPs, manage laboratory supplies, support audits, and train junior staff on CE assays and GMP practices