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Senior Quality Assurance Associate

2 months ago

Wilmington, Delaware, United States Alkermes Full time
Job Summary

Alkermes is seeking a highly motivated and experienced individual for the position of Senior Quality Assurance Associate, at the Wilmington, OH location. The successful candidate will be responsible for supporting daily compliance and systems activities, including customer complaints investigations, Annual Product Reviews, and internal audits.

Key Responsibilities:
  • Evaluate and approve customer complaints investigations
  • Write Annual Product Reviews (APRs)
  • Perform internal audits as assigned
  • Support regulatory audits
  • Notify management of any atypical trends observed in the quality systems
  • Substitute or represent the QA Manager in meetings and/or projects as needed
  • Support the QA Manager in the coordination of key responsibilities in the area of responsibility
Requirements:
  • Minimum Education & Experience Requirements: BS in scientific discipline or equivalent 8-10 years' experience in a Quality Assurance role in the pharmaceutical industry; preferably with parenteral and oral dosage forms
  • Broad experience handling customer complaints investigations and approval
  • Knowledge/Skills Needed: Working knowledge of US and European Drug Product GMP requirements and associated guidelines with ability to increase others knowledge
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.

We actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger.