Quality Control Specialist
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Qualifications:
- Must have at least one year of Quality Assurance experience in a cGMP environment.
- Must have a bachelor s degree in Life Science.
- Must have a good knowledge of Current Good Manufacturing Practices, preferably 21CFR Part 111, 211, IPEC, ICH Q7, FSSC 2200, and food safety.
- Must possess a basic understanding of chemical and microbiological analysis and basic math.
- Must be able to work in a fast-paced environment, meet deadlines (overtime work required) and make effective decisions.
- Must be skilled in organization and prioritization, and attention to details. SAP experience is preferable.
Responsibilities:
- Review Production Batch Records and other manufacturing-related documents to verify compliance and record keeping for all mandated manufacturing processes, quality checks, testing, sampling, and sanitation activities.
- Audit quality control of raw materials, packaging components, labels, and finished products to ensure compliance with established specifications and regulatory standards.
- Review, revise, and create SOPs as needed.
- Assist in the implementation of policies, operating procedures, quality systems and programs which ensure proper testing, evaluation, inspection, and technical support in order to meet product quality standards.
- Act as QA reviewer for investigations, deviations, complaints, and CAPAs as designated by QA Management.
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