Azzur Group
  • Waltham, MA, USA
  • Full Time

The Quality Assurance (QA) Specialist supports efforts and deliverables related to Quality systems and processes to establish and ensure compliance of Laboratory operations and Quality Programs. 

Essential Duties and Responsibilities

  • Prepare and perform Change Control/CAPA and internal/external Audits.
  • Evaluate processes, propose solutions, resolve issues and communicate results to support task completion.
  • Develop and complete deliverables related to QA activities/methods as needed to ensure objectives are met.

Qualifications

  • College degree and three years of QA experience in an FDA related regulatory environment is needed.
  • Strong organization, analytic, communication and interpersonal skills.
  • Knowledge and understanding of FDA and Lab (Pharmaceutical Microbiology) regulations/operations.
  • Proficiency using computer software and systems related to performing QA activities.
Azzur Group
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