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.
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