- Responsible for performing the inspection of in-process product, and the appropriate documentation
- Assures cGMP compliance all at times in the production floor
- 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
- Inspect and approve rooms, lines and equipment prior to use by manufacturing and R&D personnel
- Approve components for in-process operations
- Monitor manufacturing and packaging 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 and good documentation practices.
- Inform management of problems, failures and deviations from established internal and regulatory standards
- Apply disposition status 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
- Any other required duties assigned by the immediate supervisor
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| QUALIFICATIONS: |
- Associate degree or equivalent work experience
- 1 - 3 years’ experience in quality control of a manufacturing environment
- Bilingual (English and Spanish) required
- Knowledge in cGMP regulations and FDA guidelines
- Detailed oriented
- Basic computer and math skills
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