QA Specialist II. Quality Assurance, MAPS
Nitto Denko Corp. · Town of La Grange, Wisconsin, United States
Chemical Manufacturing · 10,001+ employees
About the role
Review GMP technical documentation and analytical equipment qualifications to ensure compliance with FDA and ICH standards. Collaborate with operations teams to resolve findings, manage deviations, and support regulatory inspections.
What they look for
Requirements
Requires experience in quality assurance within a cGMP environment and familiarity with FDA regulatory requirements. Candidates must be proficient in reviewing technical reports, SOPs, and investigation documentation.
Full description
Summary
Review GMP technical documentation to ensure quality standards are met and compliant with applicable SOPs, US FDA 21CFR210, 211, 11 and applicable ICH guidance documents. Revise QA procedures to strengthen cGMP compliance.
Key Job Responsibilities
- Review test results and supporting technical documentation. Work directly with operations SMEs to resolve findings noted during the review process.
- Performing release of raw materials and consumables.
- Review and approve analytical equipment qualification documents.
- Reviewing and approving Certificate of Analysis for raw materials, drug substance and drug products.
- Supporting effectively with operations management to review and approve: SOPs, protocols, reports, equipment qualifications and calibrations, change controls, specifications trend reports and other quality documentation such as deviation and OOS investigation.
- Support writing/revising Quality Assurance procedures to strengthen compliance with cGMPs.
- Providing QA support during cGMP compliance inspections of the facility by clients, the FDA and/or other regulatory bodies.
- Support QA management with the support needed for compliance training.
- Maintaining workspace cleanliness by adhering to the 5S method of organization.
- Abiding by safe work practices and adhere to general safety rules, performing all duties in a safe manner and never placing yourself or those around you in an unsafe condition. Report all unsafe conditions to your supervisor.
- This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as management may deem necessary.
