Quality Assurance Operations Specialist

QA Operations SpecialistKey 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.QualificationsExperience: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.

Created: 2025-01-28