Proclinical is currently recruiting for a QA/QC Specialist with a biopharmaceutical company located in Worcester, MA. The successful candidate will be tasked to technical support to cross-functional teams within and outside of QC for a given API or drug product. Accountable for QC CMC support for regulatory filings, trend analysis and investigation support in QC while maintaining and meeting the highest standards in quality, customer service and regulatory compliance.
- Responsible for authoring and review of regulatory filings (INDs/ IMPDs/ BLA and DSUR).
- Responsible for providing Investigation support and lead the root case analysis.
- Exception Request (ER) and CAPA management.
- Perform Stability trend analysis.
- Delivery of files samples.
- Filing of GMP documentation.
Skills and Requirements:
- 8+ years of direct experience in biopharmaceutical or related industry is required.
- Thorough knowledge of Quality Assurance operations.
- 6+ years of experience in application of FDA/GMP regulations.
- Strong communication skills, tact, and diplomacy are critical.
- Must be effective in multidisciplinary teams and work effectively across the organization.
- Direct regulatory interface experience is preferred.
If you are having difficulty in applying or if you have any questions, please contact Jarred Fetterman at 215-531-5593.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.