Quality Lab Specialist
On-siteGrand Rapids, Michigan, United States
Job Summary
Execute chemical and physical analyses on raw materials, intermediates, and finished products using HPLC, GC, and other instrumentation to guarantee compliance with 21CFR Part 211. Perform method transfer, recovery studies, and TOC testing while authoring, executing, and approving laboratory validation protocols and SOPs. Analyze data to identify trends, troubleshoot out-of-specification results, and conduct root cause investigations to recommend corrective actions. Generate Certificates of Analysis for each batch and ensure all activities adhere to industry regulations and safety standards. Flexibly work other shifts and extended hours as assigned.
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
- Knowledge of LC-MS
- 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
- Flexibly to work other shifts, and extended hours
Desired Qualifications
- Master's degree in chemistry
- Working LC-MS knowledge
- TOC Analysis
- TLC
- ICP-MS Analysis
- UV-Vis
- USP Compendial Testing
- Stability Program Management
- Previous experience with pharmaceutical manufacturing & testing
- Understanding of compliance requirements and regulatory expectations
- Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology
- Strong oral and written communication skills demonstrated through documentation and presentations
- Ability to train and mentor junior scientists
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