QC Analytical Supervisor (2nd Shift)
The Quality Control team is looking for a QC Analytical Supervisor (2nd Shift) to join their team at the AbbVie Bioresearch Center in Worcester, MA.
This QC Analytical Supervisor will be responsible for supervising a team of analysts in the Quality function by setting performance expectations, performance assessments, training, staff development and resolution of personnel issues.
Additionally, this resource will be responsible for:
- Performing routine analytical assays in support of production including, but not limited to reagent preparation, protein concentration measurements, HPLC assays (i.e. SEC, poros).
- Review and approve the analytical results including API, Bulk Drug Substance and /or Finished Drug Product.
- Batch record reviews.
- Provide Quality support on the manufacturing shop floor.
- Delivery of files samples and stability samples.
- Compliant investigation and management.
- Filing of GMP documentation.
- Exception Request (ER) and CAPA management.
Position will be hired based on level of experience.
- 8+ years of direct experience in biopharmaceutical or related industry is required.
- Thorough knowledge of Quality Control operations.
- 8+ 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.
- Some direct manufacturing experience is preferred.
- Direct regulatory interface experience is preferred.
- 5+ years of experience in performance of analytical methods such as HPLC required.
- 2+ years of supervisory experience required.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled