Quality Control Analyst (Contract)

How you’ll make an impact:

QC Analyst I supports commercial-level GMP testing laboratories for release and stability for multiple stages of our gene therapy products. This includes performing analytical methods, data review and trending, supporting continuous improvement of GMP systems to ensure a compliant Quality Control lab.

About the team:

Our QC Analysts interface with Analytical Development and Method Validation ensuring successful method transfer, Quality Assurance, IT, Facilities, and other cross-functional teams as required. They have a cGMP operational and technical background in cell biology, biochemistry, and/or molecular biology.

How you’ll spend your time:

• Perform cGMP analytical testing (pH, osmolality, appearance, bioassay, cell culture, flow cytometry, qPCR, and ELISA)
• Review and evaluate raw data (peer review level)
• Author SOPs/Forms and technical reports with guidance
• Initiate laboratory deviations and support investigations (IA, OOS, AR), performing assessment, authoring protocols/reports and investigation closure with guidance
• Author, review, and execute equipment validations with guidance
• Support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training)
• Execute phase-appropriate test method validation protocols as needed
• Participate in providing the necessary information for regulatory filings and inspections.
• Support CAPA/Continuous Improvement Initiatives
• Must be flexible to support shift work, if needed.

Who you are and what you’ve accomplished:

• BS with 2+ years in a biotechnology discipline and 2+ years of experience in a cGMP/GxP environment is preferred
• Hands on experience in cell culture, flow cytometry, quantitative PCR, and other bioanalytical methods such as ELISA
• Superb organizational, analytical, and communications skills and “do-what-it-takes” attitude
• A passion for addressing the critical unmet medical needs of patients
• Self-directed individual who is able to work with limited direction in a fast- paced, goal-oriented environment