Quality Assurance Associate (Document Specialist)
Current• Facilitate the lifecycle of master documents of GLP, cGMP, and internal audits; (including SOPs, validation IQ, OQ & PQs, test methods, protocols, reports, specifications, memos, etc.) by functioning as a document workflow coordinator.• Coordinate in routine audits (Internal audit, Partner audit) of maintained documents to ensure that all documents were accounted for and current in MyQumas (EDMS).• Support audit and inspection readiness response activities for Federal Drug Administration (FDA), and other health authority inspections.• Prepares audit reports and performs follow-up to obtain resolutions that are compliant with regulations and satisfactory to all parties.• Participate in the document change control process, ensuring proper review, approval, and implementation of changes in a controlled manner.• Manage and document Corrective and Preventive Actions (CAPA) related to quality deviations, ensuring proper tracking, resolution, and closure of CAPA.• Responsible for issuing, executing, closing, and filling control documentation for the site (including logbooks, procedures, test methods, specifications, batch documentation, and labels) and maintained an issuance log.• Assured applicable site personnel were adequately trained in the principles, policies, and procedures of the document management system.• Assist in developing strategies to increase quality satisfaction levels.