Quality Assurance Specialist

4 weeks ago


Rahway, New Jersey, United States AA2IT Full time

Job Title: Quality Assurance Specialist

Job Summary:

We are seeking a Quality Assurance Specialist to join our team at AA2IT. The successful candidate will be responsible for managing deviations and customer complaints, including coordination, review, and approval of deviations and complaint investigations.

Key Responsibilities:

  • Review and approve deviation reports and document in Client quality systems as appropriate.
  • Notify External Manufacturing sites of customer complaints and internal complaints upon receipt.
  • Review and approve complaint investigations and document in Client quality systems.
  • Follow up with External Partners to ensure investigations are completed in a timely manner and escalate for support as necessary.
  • Collaborate with other team members to perform second person reviews of stability protocols when necessary.
  • Assist with reference standard requests as needed.

Requirements:

  • BA/BS/MS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) with minimum 4-6 years of relevant experience within complaints management, deviations, and complaint investigations.
  • Previous experience within the pharmaceutical industry or Medical Devices Combination Products with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control.
  • Must have working knowledge of regulatory expectations for the manufacture and/or testing of pharmaceutical products and/or Medical Devices Combination Products, with experience in quality, manufacturing, process validation, and/or process technology transfer processes.
  • Experience with Quality functions through execution of activities such as investigations, corrective actions, complaints management, quality system management, etc.

Preferred Qualifications:

  • Knowledge and competency with SAP and Trackwise.
  • Familiarity with Ariba and Veeva Vault a plus.

AA2IT is an equal opportunities employer.



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