Quality Assurance Operations Specialist Job at Confidential Jobs, Watertown, MA

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  • Confidential Jobs
  • Watertown, MA

Job Description

Key Responsibilities:

  • Ensure executed Manufacturing Batch Records (MBRs) are reviewed thoroughly for compliance with regulatory standards and internal procedures.
  • Oversee the release of raw materials for manufacturing processes, ensuring proper documentation and compliance with quality requirements.
  • Approve and manage deviations, ensuring appropriate investigations, root cause analysis, and corrective/preventive actions are implemented.
  • Work closely with manufacturing, quality control, and other relevant departments to ensure smooth and compliant production operations.
  • Maintain accurate and up-to-date records, ensuring all QA documentation is complete and compliant with company policies and regulatory standards.
  • Participate in continuous improvement efforts related to quality assurance and operations efficiency.
  • Utilize Veeva for document management and quality systems to ensure all records are properly handled, reviewed, and archived.

Qualifications

Experience:

  • A minimum of 3 years of experience in QA Operations, preferably within a regulated industry (pharmaceuticals, biotechnology, etc.).

Knowledge & Skills:

  • Strong understanding of manufacturing processes, MBR review, and raw material release.
  • Experience with approving deviations, investigating quality issues, and implementing corrective actions.
  • Experience with Veeva or similar document management and quality systems is a plus.

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