Quality Lab Specialist
On-siteGrand Rapids, Michigan, United States
Job Summary
Execute chemical and physical analyses on raw materials, intermediates, and finished products using instrumentation such as HPLC, GC, and Karl Fisher to guarantee compliance with 21CFR Part 211. Perform method transfer, verification, recovery studies, and TOC testing while authoring, executing, and approving laboratory validation protocols and standard operating procedures. Analyze data to identify trends, troubleshoot out-of-specification results, and conduct root cause investigations in collaboration with production. Generate Certificates of Analysis, ensure label claims adhere to specifications, and participate in internal and external audits. Train new quality chemists and mentor junior scientists while contributing to continuous improvement initiatives. Flexibly work other shifts and extended hours as needed.
Required Qualifications
- Knowledge of analytical chemistry at a level normally acquired through completion of a bachelor's degree in chemistry or equivalent
- 3 years' work experience in a chemistry analytical laboratory
- Proficiency and understanding in analytical techniques and instruments
- Understanding of complex laboratory analysis including chromatographic (both HPLC and GC), spectroscopic, and bioassay Analysis
- Working LC-MS knowledge
- TOC Analysis
- TLC
- ICP-MS Analysis
- UV-Vis
- USP Compendial Testing
- Stability Program Management
- Method qualification, validation, and transfer
- Previous experience with pharmaceutical manufacturing & testing
- Understanding of compliance requirements and regulatory expectations
- Demonstrated strong problem-solving skills
- Demonstrated proficiency in Root Cause Analysis methodology
- Demonstrated strong interpersonal interaction skills
- Ability to work in cross functional teams as well as across networks
- Exceptional attention to detail and accuracy in documentation
Desired Qualifications
- Master's degree in chemistry
- Preferred training completion
- Strong oral and written communication skills demonstrated through documentation and presentations
- Exceptional attention to detail and accuracy in documentation
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