QC Analytical Supervisor (2nd Shift)

Worcester, MA, US
Oct 09, 2018
Required Education
Bachelors Degree
Position Type
Full time
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