Quality Control Analyst

We are seeking a QC Analyst to support laboratory testing and quality control activities in a biotechnology or pharmaceutical environment. The ideal candidate will have experience with analytical testing, GMP compliance, laboratory documentation, and quality systems.

Key Responsibilities

• Perform analytical testing of raw materials, intermediates, and final products using techniques such as Flow Cytometry, ELISA, qPCR, and cell-based bioassays.
• Review laboratory data, test records, and documentation to support in-process testing and drug substance and drug product release.
• Assist with laboratory instrument calibration, routine maintenance, and laboratory readiness.
• Prepare and revise Standard Operating Procedures (SOPs), qualification and validation protocols, and reports.
• Support out-of-specification (OOS) investigations, deviations, and root cause analysis.
• Monitor compliance with GMP requirements, established procedures, and applicable quality systems.
• Review proposed changes to laboratory procedures, methods, and systems.
• Track laboratory metrics and support continuous improvement initiatives.
• Communicate testing updates and collaborate with scientific and technical teams.

Qualifications

• Bachelor’s degree; OR an associate degree with at least 2 years of relevant biotechnology or related industry experience, including Quality Control experience; OR a high school diploma with at least 3 years of relevant biotechnology or related industry experience, including Quality Control experience.
• Knowledge of GMP, SOPs, laboratory practices, and quality control processes.
• Experience with analytical techniques such as Flow Cytometry, ELISA, PCR/qPCR, or cell-based bioassays.
• Familiarity with OOS investigations, deviations, and root cause analysis.

Preferred Qualifications

• Experience in the biotechnology or pharmaceutical industry.
• Experience supporting analytical testing and biopharmaceutical product release.