Manufacturing Quality Specialist
Pharma Universe
Piscataway, new jersey
The Manufacturing Quality Specialist is responsible for ensuring compliance with cGMP regulations, company policies, and customer expectations by supporting manufacturing operations through documentation review, quality event management, and process oversight. This role requires expertise in upstream and downstream biologics processes, quality systems, and regulatory requirements to ensure the highest standards of product quality and compliance.
Responsibilities:
- Perform inspection, sampling, and testing (where applicable) on incoming materials, packaging components, and returned goods following detailed written procedures.
- Ensure smooth flow of raw material and critical material testing through routine follow-up with internal and external laboratories.
- Perform cleaning and sanitization of ISO 7 areas and ISO 5 laminar flow hoods per written procedures.
- Assign and verify expiry dates and retest dates for all GMP raw...