Lab Chemist II

Summary

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.

Key Responsibilities

• 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.

Education and Experience

• Minimum BA/BS degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum 6–10 years of experience in a pharmaceutical, dietary supplement, quality control, analytical development, food, or other GMP-regulated laboratory environment preferred.
• Demonstrated experience with advanced analytical techniques and instrumentation, including HPLC, GC, UV-Vis, FTIR, Karl Fischer, and dissolution testing.
• Experience with method development, verification, validation, method transfer, laboratory investigations, OOS/OOT, CAPA, and compendial testing preferred.
• Experience working within a cGMP-regulated analytical laboratory and supporting testing requirements for manufacturing and product release.

Knowledge, Skills and Abilities

• Strong working knowledge of 21 CFR Part 111, cGMP laboratory requirements, Good Documentation Practices, and applicable USP and compendial standards.
• Strong knowledge of analytical chemistry, analytical procedures, laboratory controls, and quality control requirements.
• Ability to independently operate and troubleshoot advanced laboratory instrumentation, including HPLC, UHPLC/MS, GC, UV-Vis, FTIR, Karl Fischer, ICP-MS and dissolution equipment.
• Ability to perform complex mathematical calculations associated with analytical testing, including preparation of standards, dilutions, concentrations, potency calculations, and result calculations.
• Ability to prepare standards, reagents, solutions, mobile phases, and dissolution media.
• Ability to interpret chromatographic and analytical data and identify potential methods, instrument, sample preparation, or data-quality concerns.
• Ability to interpret USP and other applicable compendial requirements and provide technical guidance to laboratory personnel.
• Ability to conduct scientifically sound laboratory investigations, evaluate potential root causes, and support effective CAPA development and implementation.
• Knowledge of laboratory sampling, analytical testing, documentation, data integrity, and compliance requirements.
• Ability to review analytical data and recognize OOS, OOT, atypical, or potentially invalid results requiring further evaluation.
• Proficiency with laboratory software, chromatography data systems, and general computer applications, including Microsoft Word, Excel, and PowerPoint.
• Strong written and verbal communication skills.
• Strong attention to detail, organization, technical judgment, analytical thinking, and problem-solving ability.
• Ability to work independently, manage multiple testing priorities, provide technical support to other analysts, and maintain appropriate turnaround times in a fast-paced manufacturing environment.

Physical/Work Environment/Expectations