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Perform Quality Assurance tasks such as sampling, inspections, and tests designed to ensure manufactured products are in compliance with internal SOP’s, Safety initiatives, Company policies, FDA and DEA regulations. Document all work performed, ensuring accuracy and thoroughness. Inform management of any deviations from established standards/procedures.
Job Responsibility:
Inspect and approve rooms, lines and equipment prior to use by manufacturing and R&D personnel
Approve components for in-process operations
Monitor manufacturing areas for compliance with internal SOPs, cGMPs and FDA/DEA regulations
Document all work activity in appropriate batch records, forms, and logs to ensure accuracy and compliance
Sample in-process items, and finished products
Perform required inspections and testing of in-process items and finished products
Process and distribute samples to different departments
Review records for cGMP compliance for accuracy and thoroughness
Inform management of problems, failures and deviations from established internal and regulatory standards
Apply disposition sticker to components and in-process materials
Issue QA Alerts whenever any questionable component, in-process material or product is identified at any stage of production or storage