QA Specialist II. Quality Assurance, MAPS

Nitto Denko Corp. • Town of La Grange, WI

11d

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

• Review GMP technical documentation
• Ensure quality standards are met
• Ensure compliance with applicable SOPs, US FDA 21CFR210, 211, 11 and applicable ICH guidance documents
• Revise QA procedures to strengthen cGMP compliance
• Review test results and supporting technical documentation
• Work directly with operations SMEs to resolve findings
• Perform release of raw materials and consumables
• Review and approve analytical equipment qualification documents
• Review and approve Certificate of Analysis for raw materials, drug substance and drug products
• Support 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
• Provide QA support during cGMP compliance inspections
• Support QA management with compliance training
• Maintain workspace cleanliness by adhering to the 5S method of organization
• Abide by safe work practices and adhere to general safety rules
• Perform all duties in a safe manner
• Never place yourself or those around you in an unsafe condition
• Report all unsafe conditions to your supervisor

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed