Quality Assurance Specialist

2 weeks ago


Maple Grove, Minnesota, United States Actalent Full time

About the Role

As a Quality Specialist at Actalent, you will play a vital role in ensuring the quality of blood products. This is an exciting opportunity to join our team and contribute to the success of our clients.

Job Description

We are seeking a skilled Quality Specialist to independently review and approve product documents, identify and resolve quality issues, and monitor production and laboratory operations for compliance with cGMPs and procedures. You will be responsible for reviewing and approving change orders, investigations, non-conforming events, CAPAs, and other associated activities. Additionally, you will create and revise QMS procedures as needed and implement changes to improve effectiveness and efficiency.

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 work independently with limited supervision
  • Good listening, verbal, and written communication skills
  • Effective presentation skills for staff and department meetings

Benefits

  • Medical, dental & vision benefits
  • Critical Illness, Accident, and Hospital benefits
  • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
  • Life Insurance (Voluntary Life & AD&D for the employee and dependents)
  • Short and long-term disability benefits
  • Health Spending Account (HSA)
  • Transportation benefits
  • Employee Assistance Program
  • Time Off/Leave (PTO, Vacation or Sick Leave)


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