Our client is seeking a Contract Quality Assurance Specialist near Boston, MA!
Our client is an integrated global leader in pharmaceutical synthesis & specialty ingredients, delivering outstanding performance, unrivaled market responsiveness, and tailored-made solutions to its customers. The company offers their customers custom-development small-molecule active pharmaceutical ingredients as well as in vitro diagnostic services. They are a mid-sized company that is experiencing growth, offering an upside to potential upward-mobility in the future.
- Proactively perform Quality Assurance functions in compliance with cGMP applying regulations IVH Q& and 21 CFR 211
- Contribute to daily Quality Assurance Operations
- Product release
- Review, edit, and approval of controlled quality documentation
- Quality investigations
- Inspection/internal audits
- Supplier qualification
- External auditing as needed
- Bachelor’s degree in a related field of science, or equivalent formal training and experience
- 2-5 years of experience in cGMP quality, regulatory, or chemical manufacturing environment
- Advanced demonstrated knowledge in…
- Analytical services
- Manufacturing (including batch processing & record review)