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Project Coordinator, Quality Assurance (QA) II

Mettawa, IL 60048

Posted: 08/18/2022 Employment Type: Contract Job Category: Quality and Compliance Job Number: 434851 Is job remote?: Yes Country: United States

Job Description

Develop, negotiate, and write new and revised Quality Agreements for R&D (Lake County and Ludwigshafen Germany, Japan, and Singapore and Operations (with R&D involvement) as needed. Duties include but not limited to:
• Interpret, explain and apply the applicable current GMP/GDP regulations, guidelines, policies and procedures
• Manage Quality Agreement life cycle; lead the conduct of cross-functional periodic review evaluations of Quality Agreements to ensure that the Agreements remain current; withdraw/terminate Quality Agreements, as applicable
• Manage processes for the timely QA writing/review/approval of Quality Agreement related policies, processes, procedures, templates, and other documentation
• Identify, lead / facilitate process improvement and efficiency projects pertaining to GxP Compliance within R&D and between R&D and Operations or Third Parties
• Collect, analyze and report metrics pertaining to GxP Compliance
• Support audit activities with respect to Quality Agreements and other Quality System elements, responding to audit requests, subject matter expert resource
• Effectively communicate audit results, both orally and in writing. Review corrective action plans / audit responses for adequacy and approve if adequate.
• Review GxP Service Provider business contracts/agreements and related documents for Quality related subject matter to ensure compliance with current regulations/guidance/industry standards and  Quality System requirements
Bachelor's degree; preferred in physical science, life science, pharmacy, business, or engineering. Minimum 5 years total combined experience required related to the following (not the sum or):
o 7+ years’ experience in Quality Assurance
o 5-7 years’ experience in Quality Assurance / Regulatory Affairs (Pharmaceutical preferred)
o 5-7 years’ Clinical Research Development / Manufacturing, finishing or analysis of investigational drug supplies

?*CO candidates may not be considered
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