QA Specialist II. Quality Assurance, MAPS
Nitto Denko•Irvine, CA
About The Position
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.
Requirements
- GMP technical documentation review
- Compliance with applicable SOPs, US FDA 21CFR210, 211, 11 and applicable ICH guidance documents
- Revision of QA procedures
- Review of test results
- Release of raw materials and consumables
- Review and approval of analytical equipment qualification documents
- Review and approval of Certificate of Analysis for raw materials, drug substance and drug products
- Review and approval of SOPs, protocols, reports, equipment qualifications and calibrations, change controls, specifications trend reports, deviation and OOS investigations
- Support for compliance training
- Adherence to 5S method of organization
- Adherence to safe work practices and general safety rules
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
