Quality Assurance Specialist

3 weeks ago


Saco, Maine, United States MMQCI Full time
Job Summary

Maine Molecular Quality Controls, Inc. (MMQCI) is seeking a Quality Assurance Specialist to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring compliance with regulatory requirements and maintaining our Quality System.

Key Responsibilities
  1. Maintain and update Quality System documentation, including Standard Operating Procedures (SOPs), Master Batch Records, and Corrective and Preventive Actions (CAPAs).
  2. Collaborate with Manufacturing to support and document Material Review Notices (MRNs) and CAPAs.
  3. Conduct internal and supplier audits to ensure compliance with regulatory requirements.
  4. Support FDA and customer audits to ensure MMQCI's Quality System meets regulatory standards.
  5. Assist in the assembly of Device Master Records for new products.
  6. Maintain training documentation for all MMQCI employees.
Requirements
  1. Bachelor of Science degree in Life Sciences and at least 5 years of experience in a cGMP regulated facility.
  2. Excellent communication and computer skills, including Excel.
  3. Strong attention to detail and ability to multitask in a dynamic environment.
  4. Knowledge of current GMP regulations and ISO 13485 is preferred.
  5. Ability to work independently and as part of a team.
Benefits
  • Medical and dental insurance
  • 401(k) and profit sharing plan
  • Vacation and holidays
  • Sick leave


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