Chemistry Lab Consultant, Medical Devices Summary Our client, a Fortune 500 medical device company, is seeking a Chemistry Lab Consultant to support Product Development R&D team in Cary, IL. Over the past two years, the team has established in-house chemistry and microbiology lab capabilities. The consultant will assess, benchmark, and optimize lab operations to ensure the team is functioning as a compliant, efficient, and well-controlled R&D environment capable of supporting routine testing, developmental work, and stability studies. Responsibilities Establish lab processes and workflows for the R&D analytical lab. Benchmark existing operations and identify improvements to align with GMP/GLP expectations. Ensure proper segregation of materials, method development, and validation processes are established and documented. Review IQ/OQ activities previously performed by vendors and ensure calibration and preventive maintenance are effectively managed. Guide chemists in proper lab practices, method validation, and reliability testing to strengthen overall lab performance. Create or refine standard operating procedures (SOPs) and quality documentation to ensure regulatory compliance. Mentor and support lab staff in day-to-day operations, ensuring best practices in sample handling, equipment use, and data integrity. Collaborate with R&D leadership to transition the lab into a fully GLP/GMP-compliant environment. Define and monitor Key Performance Indicators for lab efficacy, turnaround time, and data accuracy. Conduct audits and gap assessments to identify and mitigate risks in data handling and record keeping. Requirements Bachelor’s or Master’s degree in Chemistry, Biochemistry, or related scientific discipline. 5-8+ years of experience managing or leading operations in an analytical chemistry lab within an FDA-regulated, GMP/GLP environment. Proven track record in workflow optimization, data integrity systems, and laboratory digitalization. Strong understanding of lab infrastructure setup, instrument qualification (IQ/OQ/PQ), and quality processes. Experience working in medical device and pharmaceutical industries required. Hands‑on expertise with method development, calibration, and preventive maintenance. Experience with Analytical chemistry lab required. Experience with microbiology is a plus. Terms & Start Onsite 5 days/week in Cary, IL 6+ month contract Start ASAP Benefits included (Medical, Dental, Vision) #J-18808-Ljbffr GForce Employment Professionals, LLC
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