Job Description
Job Description
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)
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