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3rd shift position (10pm-6:30am )
QA Inspector
**Must be able to train for the first month on 1st shift**
Overview
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.
Responsibilities
- 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.
- Perform swab and Rodac Plate sampling as required.
- Perform transactions in JD Edwards when required.
Education / Experience:
High school diploma or equivalent. Basic computer skills required. Basic math skills required (i.e., calculating %, addition, subtraction, multiplication, division). Ability to read, write, communicate and follow instructions (verbal and written) in English is required.
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