Quality Assurance Specialist III

QC testing pH, water content, assay titration, Loss on drying. UV. FTIR, HPLC, GC., mineral and microbiology The candidate also familiar with USP. EP. JP compendial testing.

US FDA 21CFR210, 211, 11 and applicable ICH guidance documents. Develop and revise QA procedures to strengthen cGMP compliance.

Reviewing test results and supporting technical documentation. Work directly with operations management to resolve findings noted during the review process.

Performing release of raw materials and consumables.

Reviewing and approving Certificate of Analysis for raw materials, drug substance and drug products.

Collaborating effectively with operations management to review and approve: SOPs, protocols, reports, equipment qualifications and calibrations, change controls, specifications trend reports and other quality documentation.

Responsible for writing/revising Quality Assurance procedures to strengthen compliance with cGMPs.

Reviewing and approving deviations and gather/issue quality metrics reports to QA management.

Providing QA support during cGMP compliance inspections of the facility by clients, the FDA and/or other regulatory bodies.

Acting as a co-auditor during supplier/internal quality audits

Providing subject matter expertise for the supplier assurance program at the site

Providing 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.