Lab Chemist II

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Full Time Riviera Beach, US

3 days ago Requisition

The Lab Chemist III is a senior-level laboratory position responsible for performing complex chemical and analytical testing in support of raw materials, in-process materials, stability samples, and finished dietary supplement products. This position operates in accordance with 21 CFR Part 111, applicable cGMP requirements, approved specifications, compendial standards, laboratory procedures, and Good Documentation Practices (GDP). The Lab Chemist III is expected to independently perform advanced analytical testing, support method development and validation activities, lead laboratory investigations, troubleshoot complex analytical methods and instrumentation, and provide technical guidance and training to other laboratory analysts.

• Perform routine and complex analytical testing using techniques including titration, UV-Vis, FTIR, Karl Fischer, Loss on Drying, Residue on Ignition, dissolution, HPLC, UHPLC/MS, ICP-MS and GC.
• Independently perform analytical testing of raw materials, in-process materials, stability samples, and finished products in accordance with approved specifications, test methods, and applicable compendial requirements.
• Perform method development, verification, validation, optimization, and transfer for analytical test methods using applicable laboratory techniques and instrumentation.
• Review and evaluate analytical data for accuracy, completeness, compliance with specifications, and adherence to approved methods and procedures.
• Perform and support Out-of-Specification (OOS), Out-of-Trend (OOT), atypical result, deviation, and laboratory investigations, including scientifically sound root-cause analysis and development of appropriate corrective and preventive actions (CAPA).
• Troubleshoot analytical methods, laboratory equipment, instrumentation, and testing issues and provide scientifically sound recommendations for resolution.
• Prepare laboratory solutions, reagents, reference standards, mobile phases, dissolution media, and other materials required for analytical testing.
• Operate, maintain, and troubleshoot laboratory instruments, including analytical balances, pH meters, UV-Vis, FTIR, Karl Fischer, dissolution equipment, HPLC, UHPLC/MS, GC, ICP-MS and other applicable analytical equipment.
• Ensure laboratory equipment is appropriately qualified, calibrated, maintained, and documented prior to use.
• Ensure established specifications, test methods, and acceptance criteria are appropriately followed when testing components, raw materials, in-process materials, stability samples, and finished products.
• Maintain complete, accurate, contemporaneous, attributable, and traceable laboratory records, worksheets, logbooks, electronic data, calculations, chromatograms, and supporting documentation in accordance with cGMP and GDP requirements.
• Support laboratory compliance with applicable USP, compendial, regulatory, 21 CFR Part 111, and company requirements.
• Provide technical guidance and interpretation of compendial requirements, analytical procedures, specifications, and laboratory practices to other analysts.
• Train and mentor laboratory analysts on analytical methods, laboratory instrumentation, troubleshooting, cGMP requirements, Good Documentation Practices, and approved laboratory procedures.
• Evaluate analyst proficiency and assist with training qualification and competency development.
• Assist with development, review, and revision of SOPs, analytical methods, specifications, protocols, validation reports, and other controlled laboratory documentation.
• Support stability testing programs, including timely testing, data review, trending, and identification of potentially adverse or atypical results.
• Support laboratory continuous improvement initiatives related to analytical methods, instrumentation, testing efficiency, data quality, and laboratory compliance.
• Support internal audits, customer audits, regulatory inspections, and third-party certification audits by providing laboratory documentation and technical expertise.
• Promptly communicate laboratory results, testing delays, OOS/OOT results, atypical findings, equipment issues, and potential quality concerns to Laboratory and Quality management.
• Perform other duties as assigned.

• Minimum BA/BS degree in Chemistry,…