Lab Chemist I

Summary

The Lab Chemist I is an entry-level laboratory position responsible for performing routine chemical and analytical testing in support 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, laboratory procedures, and Good Documentation Practices (GDP). The Lab Chemist I work under the guidance of experienced laboratory personnel while developing proficiency in analytical testing, laboratory instrumentation, documentation, and cGMP laboratory practices.

Key Responsibilities

• Perform routine analytical testing using established techniques, including titration, UV-Vis, FTIR, Karl Fischer, Loss on Drying, Residue on Ignition, rupture test, weighing and other approved analytical methods as trained and qualified.
• Perform testing of raw materials, in-process materials, stability samples, and finished products according to approved specifications, test methods, SOPs, and applicable compendial requirements.
• Assist with or perform HPLC, dissolution, and other instrumental testing following successful training and qualification.
• Prepare laboratory solutions, reagents, standards, mobile phases, dissolution media, and other materials required for analytical testing.
• Operate routine laboratory equipment, including analytical balances, pH meters, UV-Vis, FTIR, Karl Fischer, and other applicable instrumentation for which the analyst has been trained and qualified.
• Follow established specifications, test methods, sampling procedures, and acceptance criteria when performing laboratory testing.
• Review calculations and test results for accuracy and completeness prior to submission for laboratory review.
• Promptly report Out-of-Specification (OOS), Out-of-Trend (OOT), atypical, questionable, or unexpected results to Laboratory and Quality management in accordance with established procedures.
• Support laboratory investigations by providing testing records, data, calculations, and other information as requested.
• Maintain complete, accurate, contemporaneous, attributable, and traceable laboratory records, including worksheets, logbooks, electronic data, calculations, and supporting documentation in accordance with cGMP and GDP requirements.
• Ensure laboratory instruments and equipment are within required calibration, qualification, and maintenance status prior to use.
• Follow established procedures for proper handling, identification, storage, and control of samples, standards, reagents, and laboratory materials.
• Support stability testing activities and ensure assigned testing is completed within established timelines.
• Assist with laboratory equipment checks, routine maintenance, inventory, and general laboratory organization.
• Follow applicable USP, compendial, 21 CFR Part 111, cGMP, safety, and company requirements.
• Complete required training and demonstrate proficiency before independently performing assigned analytical methods or operating laboratory instrumentation.
• Support internal audits, customer audits, regulatory inspections, and third-party certification audits as requested.
• Promptly communicate testing delays, equipment issues, documentation concerns, and potential quality issues to Laboratory management.
• Maintain laboratory cleanliness, safety, and organization in accordance with established procedures.
• Perform other duties as assigned.

Education and Experience

• Minimum BA/BS degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
• 0–2 years of laboratory experience in a dietary supplement, pharmaceutical, food, quality control, analytical development, or other regulated laboratory environment preferred.
• Previous academic or professional experience with basic analytical chemistry techniques and laboratory instrumentation preferred.
• Previous experience in a cGMP-regulated laboratory is preferred but not required.

Knowledge, Skills and Abilities

• Basic knowledge of analytical chemistry principles and laboratory practices.
• Basic understanding of 21 CFR Part 111, cGMP, Good Documentation Practices, and applicable compendial requirements, or ability to develop proficiency through training.
• Ability to operate basic laboratory equipment, including analytical balances, pH meters, UV-Vis, FTIR, and Karl Fischer, following appropriate training and qualifications.
• Ability to learn and develop proficiency with more advanced analytical instrumentation, including HPLC and dissolution equipment.
• Ability to perform laboratory calculations involving standards, dilutions, concentrations, and analytical results.
• Ability to prepare standards, reagents, solutions, mobile phases, and dissolution media according to approved procedures.
• Ability to accurately follow SOPs, analytical methods, specifications, and written laboratory instructions.
• Understanding the importance of data integrity, accurate documentation, sample traceability, and cGMP compliance.
• Ability to recognize unexpected or questionable analytical results and promptly escalate them for further evaluation.
• Proficiency with general computer applications, including Microsoft Word and Excel, and ability to learn applicable laboratory software and data systems.
• Strong attention to detail, organization, analytical thinking, and problem-solving skills.
• Effective written and verbal communication skills.
• Ability to work both independently following qualification and collaboratively as part of the laboratory team.
• Ability to manage assigned testing priorities and meet established laboratory turnaround times.

Physical/Work Environment/Expectations