AbbVie QC Analytical Supervisor (2nd Shift) in Worcester, Massachusetts
QC Analytical Supervisor (2nd Shift)
USA, Massachusetts, Worcester
Manufacturing & Operations
The Quality Control team is looking for a QC Analytical Supervisor (2 nd 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