SummaryThe Lab Chemist II is responsible for performing chemical, analytical, of raw materials, in-process materials, stability samples, and finished dietary supplement products. This position performs laboratory activities in accordance with 21 CFR Part 111, applicable cGMP requirements, approved specifications, compendial standards, Standard Operating Procedures (SOPs), and Good Documentation Practices (GDP). The Lab Chemist II independently performs routine and moderately complex testing, supports laboratory investigations and method activities, and assists with environmental monitoring.

Key ResponsibilitiesPerform routine and moderately complex analytical testing using techniques including titration, UV-Vis, FTIR, Karl Fischer, Loss on Drying, Residue on Ignition, dissolution, HPLC, and GC, as applicable.

Independently perform testing of raw materials, in-process materials, stability samples, and finished products according to approved specifications, test methods, and applicable compendial requirements.

Prepare standards, reagents, solutions and other materials required for laboratory testing.

Operate laboratory instrumentation including analytical balances, pH meters, UV-Vis, FTIR, Karl Fischer, dissolution equipment, HPLC, GC, incubators, and other applicable equipment.

Perform routine instrument troubleshooting and ensure laboratory equipment is appropriately calibrated, qualified, maintained, and suitable for use.

Review and evaluate test results against established specifications and promptly communicate OOS, OOT, atypical, or questionable results to Laboratory and Quality management.

Participate in laboratory investigations, including data review, root-cause analysis, retesting activities when scientifically justified and approved, and CAPA implementation.

Maintain complete, accurate, contemporaneous, and traceable laboratory records, worksheets, logbooks, electronic data, and supporting documentation in accordance with cGMP and GDP requirements.

Assist with compilation and trending of analytical, microbiological, environmental monitoring, and purified water data.

Follow applicable USP, compendial, regulatory, and company requirements for laboratory testing and documentation.

Maintain appropriate laboratory controls to prevent contamination, sample mix-ups, and data integrity concerns.

Assist with training less-experienced laboratory personnel on approved test methods, laboratory procedures, and proper use of laboratory equipment, as assigned.

Support internal audits, customer audits, regulatory inspections, and third-party certification audits by providing laboratory records and technical information as requested.

Maintain laboratory cleanliness, organization, safety, and compliance with established procedures.

Perform other duties as assigned.

Education and ExperienceMinimum BA/BS degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline.

Minimum 35 years of laboratory experience within a dietary supplement, pharmaceutical, food, quality control, analytical development, or other GMP-regulated environment preferred.

Experience performing analytical testing using techniques such as HPLC, GC, UV-Vis, FTIR, Karl Fischer, dissolution, or wet chemistry preferred.

Experience with microbiological testing, environmental monitoring, water testing, or compendial laboratory methods preferred.

Experience working within a cGMP-regulated laboratory and following approved SOPs, specifications, and test methods.

Knowledge, Skills and AbilitiesWorking knowledge of cGMP laboratory practices, Good Documentation Practices, and applicable compendial requirements.

Ability to operate laboratory instruments including analytical balances, pH meters, UV-Vis, FTIR, Karl Fischer, dissolution equipment, HPLC, and GC, as applicable.

Knowledge of analytical chemistry and basic microbiological laboratory techniques.

Ability to prepare standards, reagents, solutions, mobile phases and dissolution mediaAbility to perform laboratory calculations involving concentrations, dilutions, standards, and analytical results.

Ability to perform microbiological testing and read plates for microbial enumeration and specified organisms, as applicable.

Ability to recognize potential laboratory errors, atypical results, equipment issues, and data integrity concerns and appropriately escalate them.

Basic understanding of OOS/OOT investigations, root-cause analysis, CAPA, and laboratory deviation processes.

Ability to interpret and follow approved analytical methods, SOPs, specifications, and applicable compendial requirements.

Proficiency with laboratory software and general computer applications, including Microsoft Word and Excel.

Strong attention to detail, organization, analytical thinking, and problem-solving skills.

Effective written and verbal communication skills.

Ability to work independently while recognizing when technical or Quality guidance is required.

Ability to manage multiple testing priorities and meet laboratory turnaround requirements in a fast-paced manufacturing environment.

Physical/Work Environment/ExpectationsTravel may be required for this position.

This position works within a GMP Manufacturing Environment, office environment and inside the plant.

The incumbent may be required to sit for long periods of time while doing work on a computer at a desk. Use of standard office equipment is required. While inside the plant, may be exposed to loud noises coming from equipment; may be exposed to hazardous chemicals which require the use of eye protection, and other PE depending on area within the plant.

Note:

This job description is not totally inclusive, nor is it designed to cover or contain a complete comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.