QA Operations Specialist, Cell & Gene Therapy

Our client, a leading pharmaceutical company focused on discovering, developing, manufacturing, and commercializing therapeutic treatments is currently seeking a QA Operations Specialist, Cell & Gene Therapy to join their team for a 6-month contract with the potential to extend. This person will be responsible for the day-to-day oversight and release of the incoming raw materials to support manufacturing operations and quality assurance for clinical and commercial drug product manufacturing activities.

This is a second shift position (2pm - 10pmEST)

Responsibilities

• Responsible for GMP release of incoming raw material and components per approved specifications.
• Review incoming materials against specifications and submit samples to QC Labs (internal and external) for testing
• Review and approval analytical protocols/reports, OOS results, re-test plans, etc., and associated corrective and preventive action plans
• Responsible for approval of COAs when applicable
• Experience with vendor qualifications, setting raw material specifications, managing timelines
• Support of the raw material retains program
• Support new raw material risk assessments that will consider supplier information, general industry knowledge, and technical evaluations based on process and material knowledge with a focus on suitability of each material for its intended use in the process
• Generate metrics for routine visibility and trending
• Support QA in regulatory submissions and inspections
• Communicate to material management, QA, and manufacturing of any OOS results that may impact release timelines
• Review documentation generated by QC for accuracy and GDP per company procedures
• Support non-conformance (OOT/OOS) investigations, CAPAs, risk assessments, and change controls associated with in-house testing

Salary: $30 - $35/hr

Qualifications

• BS degree required, in the biological or chemical sciences preferred.
• 0 - 1 year of QA or QC, raw material release, or inspection experience in a regulated Bio/Pharmaceutical industry with biopharmaceutical products, or biologics required.
• Demonstrated strong working knowledge of GMP manufacturing.
• Demonstrated broad working knowledge and experience of regulatory guidance and industry best practice quality control.
• Experience in leading and supporting investigations and making decisions around issues that arise during data package review.
• Experience working with Oracle systems (OPM) preferred
• Proven experience in raw material release and vendor qualifications program preferred
• Approving Technical Document Specifications to support the release activities preferred

If you are interested in this position, please send your resume to {apply below}

IND123