QC Analyst, Quality Control Laboratory

Responsibilities

• Perform and review routine in-process, release, and stability testing for biologic drug substances and drug products while adhering to GMP/GDP QC requirements
• Experience performing plate-based ELISA, ligand binding assays required
• Execute and troubleshoot a range of analytical methods including HPLC/UPLC (SEC, RP, CEX, Peptide Mapping), capillary electrophoresis testing (cIEF, CE-SDS)
• Support laboratory investigations, including OOS, OOT, and atypical result investigations
• Conduct root cause analysis and identify, implement, and verify effectiveness of CAPAs
• Draft and oversee protocols for method validation, verification, and transfer
• Interpret results, perform statistical analyses, and prepare validation reports aligned to ICH Q2 and US FDA expectations
• Author and review SOPs, test methods, protocols, and technical reports
• Maintain departmental instruments and ensure timely execution of QC quality system records
• Mentor team members and oversee analytical workflows to meet project goals

Qualifications

• Bachelor’s or Master’s in Biology, Chemistry, Biochemistry, or a related scientific field
• Minimum of 3 years of direct, hands-on QC experience in a GMP Quality Control laboratory supporting biologics
• Technical proficiency with HPLC, ELISA, capillary electrophoresis, and compendial testing
• Background in laboratory investigations, OOS management, and CAPA implementation
• Hands-on QC experience with method validation aligned to ICH Q2 and US FDA regulations
• Excellent technical writing, documentation, and analytical troubleshooting skills
• Ability to work independently while collaborating effectively across QC, QA, and Regulatory
• Experience in a commercial-stage or late-phase biologics environment is preferred
• Familiarity with LIMS and chromatography data systems (e.g., Chromeleon) is highly desirable
• Strong familiarity with GxP requirements
• Excellent communication, interpersonal and organizational skills are required

Pay

The Base Salary Range for this position is $90,000 to $110,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.