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:
- Bachelor’s degree in Life Sciences, Quality Assurance, or related field.
- Minimum of 3 years in a GMP environment, with experience in quality assurance for small and/or large molecules.
- Proficiency with a variety of analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fischer, UV, HPLC (Waters Empower software preferred), and Relative Potency Assay.
- Strong understanding of data integrity principles within a GMP framework.
- Solid technical training and troubleshooting experience in quality systems.
