Quality Assurance Operations Specialist

QA Operations Specialist Responsibilities: • Interfaces with Manufacturing, Technical Operations, Quality Control and Regulatory Affairs, as well as CMO sites to ensure compliance with regulation, specification, and Quality technical agreements. • Complies and summarizes necessary information in support of Annual Product Reviews and/or Product Quality Reviews. • With management guidance provides QA compliance operational oversite and support for internal/external manufacturing operations including review and approval of protocols and reports, master batch records, executed batch records and QC data verifications. • With management guidance coordinates, prepares and approves the release process documentation for our products including IP1, Drug Substance and Drug Products. • Assists with the management of deviations, change controls, corrective and preventive actions for operations: Provides support for Management Reviews • With management guidance interfaces with Quality Control to assist to resolve compliance needs, OOS and Assay Validation needs. • Provides support as needed in the following capacity: review of technical input on investigations, deviation, non-conformances, and change controls. • Active involvement in support of cGMP inspections from regulatory authorities. •Effectively participates in Quality Assurance system process improvements and associated training as needed. Other duties: • Prepare and review Manufacturing Production Records (MPRs) and associated labels • Aid in revisions of documents, training modules, and MPRs • Review of FVII qualification records, sample paperwork, and QC Assays • Scanning and filing of documents • Release of GMP Materials • Review of Blue Mountain Building Management System records