Quality Assurance Specialist 1 (Huron Park)

Job Function

• Designs, develops, and implements internal auditing programs and procedures consistent with the organization’s requirements
• Performs Internal Audits, to ensure that procedures are available and adhered to according to requirements for maintaining ISO/IEC 17025:2017 accreditation and GLP (Valuable Laboratory Practices) recognition.
• Performs GLP inspections to ensure that GLP studies are completed according to OECD and/or FDA GLP requirements.
• Reports audit findings to Director QA or designate and conducts post-audit meetings as necessary.
• Performs/ reviews non-conformance investigations to ensure the non-conformance has been addressed and full and proper resolution has been documented.
• Issues corrective actions in response to Quality Systems activities, tracking the progress and verifying the implementation and effectiveness of corrective actions
• Completes evaluation of supplier quality
• Arran...

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