What are the responsibilities and job description for the Quality Assurance Operations Specialist position at Confidential?
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
Salary : $30 - $40
