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Quality Assurance Lead

1 week ago

Maple Grove, Minnesota, United States Actalent Full time
About the Job
We are seeking an experienced Quality Assurance Lead to join our team at Actalent. The successful candidate will have a good understanding of GMP regulations and be able to identify and resolve quality issues in consultation with Quality Management.

Main Responsibilities
  • Independently review and approve Blood Product documents including Policies, SOPs, Work Instructions, Procedures, Plans, Study Protocols/Reports, Specifications, and Forms.
  • Review and approve change orders, investigations, non-conforming events, CAPAs, and other associated activities.
  • Identify and resolve quality issues using problem-solving skills.
  • Create and revise QMS procedures as needed.

Required Skills and Qualifications
  • 3-5 years of relevant Quality experience in pharmaceutical or medical device industry.
  • Experience and/or knowledge of pharmaceutical or medical device industry regulations.
  • Ability to communicate effectively with directors and stakeholders.