The Role:

The QC Specialist I will support QC Raw Material Program and Testing activities, including onboarding materials, conducting raw material risk assessments, conduct inspections and testing, and execute the daily operation in the laboratory. This position is responsible for QC sampling, inspection, testing and release of incoming raw materials, components and biological materials used in the production process per established procedures. The role will also support oversight and review of outsourced sampling and contract testing of raw materials.

Here’s What You’ll Do:

• Perform QC receipt, sampling, inspection, testing and release (including outsourced Analytical/Microbial and Biochemical testing) of incoming raw materials, reagents, and components.
• Support onboarding and qualification of materials and components by creating material specifications, risk assessments, and evaluating vendors and materials.
• Creation and maintenance of applicable documentation to facilitate raw material and component testing and qualification. This also includes reviewing documents updated by other departments.
• Interface with cross-functional stakeholders, including Clients, Supply Chain, Manufacturing, Manufacturing Science & Technologies, Process Development and Analytical Development.
• Maintain laboratories in a safe, cGMP compliant and inspection-ready state. This includes the 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.
• Performs routine maintenance of lab equipment.
• Assist in handling of deviation investigations, lab investigations, OOS investigations, Non-conforming Material Investigations, Supplier Correction Action Requests, and Supplier Change Notifications.
• Support execution of change controls and CAPAs to facilitate testing, qualification, system improvements and compliance.
• Maintains strict adherence to cGMP compliance and all applicable regulations.
• Supports regulatory inspections, external client and internal audits as required.

Requirements:

• BS in a scientific discipline with at least 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.)
• Experience with interpreting and applying international compendial test monographs
• Ability to communicate and work independently with scientific/technical personnel.
• Strong knowledge of GMPs, SOPs, and Quality system processes.
• Excellent organizational skills.
• Experience in cell and gene therapy manufacturing environment a plus
• Experience performing laboratory investigations, including out of specification investigations