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Quality Assurance Specialist

1 month ago

Reston, Virginia, United States GroupA Full time

We are seeking a highly skilled Quality Assurance Specialist to support our team in Hopewell, New Jersey. In this role, you will play a critical part in ensuring the quality and compliance of our pharmaceutical manufacturing processes.

Key Responsibilities:

  • Review and approve GMP documentation, including logbooks, analytical raw data, and Environmental Monitoring reports
  • Develop and maintain SOPs to support business operations
  • Support internal and external audits to ensure compliance with FDA/EU regulations
  • Implement and monitor quality assurance activities in laboratories and facility/utility spaces
  • Ensure QA compliance of departmental SOPs and awareness of USP/EP, ICH Guidelines, and QC methodology updates
  • Escalate and follow up on non-conformities and issue deviations as necessary

Requirements:

  • Scientific degree (ideally biotechnology, biology, pharmacy, pharmaceutical sciences, chemistry, or related scientific field) or equivalent work experience
  • Required 3+ years (B.S. degree) or 1 year (M.S. degree) of GMP Pharmaceutical experience in a quality assurance or quality control role in an FDA-regulated company
  • Working knowledge of cGMPs: 21CFR parts 11, 210 & 211, and knowledge of 21CFR600 – Biologics desirable
  • Microsoft Office (Word, Excel, PowerPoint, Project, and Outlook) and ERP systems such as Maximo, Veeva, and SAP