Chemist

A global Medical Device client is looking for Chemist to support our laboratory operations and ensure chemistry compliance, product quality, and regulatory excellence in a dynamic, GMP-regulated environment.

Key Responsibilities:

• Conduct sampling and chemical/physical testing on raw materials, intermediates, and final products using advanced techniques, including chromatography.
• Perform routine verification and control activities to ensure ongoing compliance.
• Lead documentation reviews, logbook checks, and maintain GMP integrity across all chemistry data.
• Coordinate and manage external lab testing, including liaison with contract laboratories.
• Own and troubleshoot OOS (Out of Specification) results, conducting investigations, NCs, and CAPAs as needed.
• Execute and peer-review equipment qualifications, test method validations, and ensure lab equipment is maintained to the highest standards.
• Serve as Subject Matter Expert (SME) and Lead Trainer, mentoring and coaching junior lab analysts.
• Manage retain sample processes, lab consumables, and testing chemicals.
• Support and lead preparations for internal and external audits.
• Own or contribute to QMS documentation including ECRs, ECNs, PEMAC forms, CDFs, and more.
• Track and report lab KPIs, and support ongoing EHS and 6S initiatives.
• Drive and implement lab improvements and cost-saving initiatives.

Qualifications & Skills:

• Bachelor's degree in Chemistry or a related discipline (or equivalent experience).
• Previous experience in a GMP-regulated or Quality/Regulatory environment preferred.
• Familiarity with US and international medical device regulations is desirable.
• Proficient in Microsoft Word, Excel, and PowerPoint; strong PC and data handling skills.
• Solid analytical and troubleshooting capabilities with a keen attention to detail.
• Ability to interpret statistical data and communicate results effectively.
• Strong independent working skills, excellent communication, and team collaboration.
• Demonstrated leadership in mentoring, coaching, or training peers.