Quality Control Analyst III

6-month contract role supporting cGMP laboratory operations in a pharmaceutical/biopharmaceutical CDMO environment.

Responsibilities

• Support QC laboratory testing using standard analytical techniques including pH, Osmolality, and FT-IR instrumentation for in-process, finished product, and stability sample analysis.
• Perform complex analytical testing including HPLC, ELISA, and other advanced techniques with independent data evaluation.
• Support and/or lead investigations of OOS events through thorough root cause analysis, assessment of potential product impact, and implementation of appropriate corrective and preventive actions (CAPAs).
• Execute, author, and review SOPs, protocols, reports, investigations, change controls, and data summaries.
• Write and revise test methods and standard operating procedures in alignment with regulatory expectations.
• Provide training to junior laboratory personnel; attend internal and external training on relevant techniques and procedures, including intra- and inter-departmental cross-training.
• Enter, track, and trend data within relevant data management systems; present data summaries to management.
• Lead the stability program including management of test points, reporting of data, and investigation of out-of-specification or aberrant stability results.

Requirements

• Bachelor's degree in Chemistry, Biology, Biochemistry, or a related life science discipline; advanced degree a plus.
• Minimum 2 to 4 years of relevant QC laboratory experience in a cGMP-regulated pharmaceutical or biopharmaceutical environment.
• Hands-on experience with complex analytical techniques including HPLC and/or ELISA.
• Demonstrated ability to independently plan, execute, and evaluate laboratory investigations and OOS events.
• Experience authoring or reviewing GMP documents including SOPs, protocols, reports, and change controls.
• Experience with data management systems and trending/tracking activities preferred.

Pay

$39–$60 per hour.

Schedule

Monday–Friday, 8:00 AM–5:00 PM. On-site in Thousand Oaks, CA.