Quality Assurance Operations Specialist - Confidential : Job Details

QA Operations Specialist

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.