Senior Quality Assurance Supervisor

4 weeks ago


Wilmington, Ohio, United States Alkermes Full time
Job Summary

We are seeking a highly skilled and experienced Senior Quality Assurance Supervisor to join our team at Alkermes. The successful candidate will be responsible for providing supervision to the Quality Assurance On-the-Floor (OTF) team, supporting sterile and oral solid dose manufacturing operations. This role will provide direct oversight for day-to-day quality and compliance of operations, developing and implementing tactical initiatives directed by Senior Management.

Key Responsibilities
  • Ensure the Quality OTF team provides adequate and appropriate support to ensure the safety, identity, strength, purity, and quality of the products manufactured and that operations are compliant with all Standard Operating Procedures, Specifications, and current Good Manufacturing Practice, and applicable Regulations.
  • Have authority to approve or reject written standards, including Master Production Records, Standard Operating Procedures, Work Instructions, Specifications, Sampling Instructions, etc.
  • Responsible for review and approval of risk assessments, change controls, investigations, corrective/preventive actions, and complaint records.
  • Participate in management processes for quality and compliance.
  • Participate in third-party inspections and completion of applicable commitments.
  • Monitor site metrics pertaining to their area to ensure adequate performance of quality systems and support management review.
  • Support data and documentation review as needed for Annual Product Reviews.
  • Responsible for ensuring that the required initial and continuing training of direct reports is carried out and adapted according to need.
  • Support the Internal Audit Program.
  • Support recall process where required.
  • Responsible for supporting and partnering with Documentation Control.
  • Responsible for the supervision of direct reports.
Requirements
  • Requires a Bachelor's degree in a scientific discipline or equivalent.
  • For QA Supervisor: 6+ years of experience in a Quality Assurance role in the pharmaceutical industry, experience with parenteral dosage forms or equivalent strongly desired. Oral Solid Dose and/or Combination Product related experience desired.
  • Proficient in Microsoft Office.
  • Knowledge of SAP, LIMS, TrackWise preferred.
About Us

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients.



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