QC Raw Materials Associate II (Contract - Multiple Openings)

The Role:

The QC Associate II will support the QC Raw Material Program. You will be primarily responsible to receive, sample, inspect, test, and release materials for use in GMP manufacture.

Here’s What You’ll Do:

• Receive, sample, inspect, test, and release incoming raw materials, reagents, and components in compliance with SOPs.  This includes maintaining compliant documentation.  This may include management of outsourced analytical, microbial, and biochemical testing. 
• Maintain laboratories in a safe, cGMP compliant and inspection-ready state. This includes maintenance of the labs in a clean and orderly manner, ensuring logbooks and associated documents are reviewed on time, ensuring all equipment are within calibration and all chemicals/reagents are within expiry. Maintain inventory of supply and reagents.
• Perform routine maintenance of lab equipment.
• Support onboarding and qualification of materials by assisting in the preparation of documentation to facilitate material release and testing as part of technology transfer.
• Maintain strict adherence to cGMP compliance and all applicable regulations.

Requirements:

• BS in a technical discipline with at least 1-5 years’ experience in GMP pharmaceutical / biotech industry within Quality Control, MSAT, Process Development or related area to Raw Materials technical expertise.
• Experience with raw material testing programs and quality control methodologies (FT-IR, Raman, NIR, Dot-blot, ELISA, HPLC, pH, Visual Inspection, etc.)
• Ability to work independently.
• Ability to communicate/collaborate with scientific/technical personnel.
• Excellent organizational skills and attention to detail.
• Knowledge of GMPs, SOPs, and Quality System processes.
• Experience with electronic management systems (SAP, Veeva, LIMS) is a plus.
• Experience in cell and gene therapy manufacturing environment is a plus.