Project Coordinator, Quality Assurance (QA) II
Mettawa, IL 60048 US
• 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
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.