QC Associate I, Raw Materials (Contract)

The QC Associate I 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.

• Responsibilities:
  Receive, sample, inspect, test, and release incoming raw materials, reagents, and components in compliance with SOPs.  This includes maintaining compliant documentation. 
• 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 0-2 years’ experience in GMP pharmaceutical / biotech industry within Quality Control, MSAT, Process Development or related area to Raw Materials technical expertise.
• Ability to communicate/collaborate with scientific/technical personnel.
• Excellent organizational skills and attention to detail.
• Experience with raw material testing programs and quality control methodologies (FT-IR, Raman, NIR, Dot-blot, ELISA, HPLC, pH, Visual Inspection, etc.) is a plus.
• Knowledge of GMPs, SOPs, and Quality System processes is a plus.
• Experience with electronic management systems (SAP, Veeva, LIMS) is a plus.
• Experience in cell and gene therapy manufacturing environment is a plus.