Quality Assurance Specialist Jobs

About The Position

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.