What are the responsibilities and job description for the QA Specialist IV position at Meet?
Position Overview :
This role involves technical writing, conducting thorough investigations, and monitoring quality system records to uphold regulatory compliance and product integrity.
Key Responsibilities :
- Provide compliance support for operational functions, particularly in Quality Control (QC), ensuring adherence to GMP standards.
- Author and revise quality system records including Out of Specification (OOS) reports, laboratory investigations, deviations, Corrective and Preventive Actions (CAPA), and change controls.
- Conduct comprehensive investigations for Laboratory Investigation Reports (LIR) and deviations, employing effective root cause analysis and risk assessment techniques.
- Ensure personnel compliance with training programs relevant to supported operational functions, fostering a culture of continuous learning and improvement.
- Manage and author change controls associated with the qualification, modification, and decommissioning of laboratory equipment, assessing impacts on systems and processes.
- Maintain high standards of technical writing, ensuring all documents are clear, concise, and completed within established timelines.
Requirements :