Our client is a leader in the pharamceutical/biopharmaceutical industry! They are in need of a Quality Specialist for their R&D program.
- Assists in developing, implementing and maintaining a specialized quality system to support the R&D programs including quality assurance for GMP and GLP supplies.
- Oversee and coordinates investigations, provides direction and guidance for investigations and executes them when needed.
- Provide Quality Systems support for complex technical projects and in troubleshooting activities.
- Assist with CDMO and product technical transfers to commercial state.
- Assist in building, maintaining and continuously improving a specialized quality system to support R&D and CDMO programs.
- Ensure Good Manufacturing Practices (cGMP) compliance in such areas as batch production and record review and retention.
- Answers customer communications and helps build a customer support program.
- Reviews completed batch records for completeness, accuracy and compliance to process parameters.
- Actively participates as quality support to R&D and the manufacturing departments that is performing the technical transfer.
- Completes Deviations and CAPAs as needed.
- Bachelor's Degree in Chemistry or related field highly preferred.
- 4+ years of similar experience in the pharmaceutical/biopharmaceutical industry.
- Experience with GMP, GLP, cGMP, and SOPs.
Salary : $60,000 – $85,000