What are the responsibilities and job description for the Quality Assurance Operations Specialist position at Confidential Jobs?
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.
