Job Description

Summary: The Quality Control Chemist III plays a senior role in the Quality Control (QC) laboratory, responsible for leading complex analytical testing and providing cross-functional support for the testing and release of raw materials and finished goods. In addition to performing advanced chemical analyses, the Chemist III supports the QC Supervisor with daily operations, mentoring junior chemists, and ensuring compliance with cGMP regulations. This role bridges technical execution with leadership by ensuring timely, accurate testing while driving continuous improvement in quality systems.

Essential Duties and Responsibilities:

• Perform advanced analytical testing on raw materials and finished goods using High-Performance Liquid Chromatography (HPLC), Gas chromatography (GC), Ultraviolet and Visible (UV-Vis), Fourier Transform Infrared Spectroscopy (FTIR), Atomic Absorption Spectrometry (AA), and other techniques, ensuring data accuracy and compliance with established specifications.
• Lead investigations of out-of-specification (OOS) results, including root cause analysis and documentation of corrective actions.
• Review and approve analytical data and Certificates of Analysis (CoAs) for accuracy and completeness prior to supervisor sign-off.
• Provide technical support and guidance to QC Chemists I and II, ensuring adherence to SOPs, test methods, and good documentation practices.
• Collaborate with the QC Supervisor to coordinate daily sample flow, prioritizing testing schedules for raw material (RM) and finished goods (FG) to meet production and release timelines.
• Support the Supervisor in ensuring timely review and disposition of RM and FG, including the verification of data used for release decisions.
• Assist in training QC staff on new test methods, instruments, and safety procedures.
• Acts as a liaison between the QC lab and other departments (QA, Production, Planning and Purchasing) for RM/FG testing needs, troubleshooting, and process improvements.
• Troubleshoot OOS results on raw materials with vendors, including coordinating retesting, reviewing vendor CoAs, and collaborating on corrective actions to ensure material compliance and timely resolution.
• Troubleshoot finished goods OOS results and escalate findings through proper Quality management channels, involving Sales and Business teams as necessary, based on management's approval.
• Perform method development and validation as needed, with documentation aligned to regulatory and internal standards.
• Participate in internal and external audits, provides data and justifications as needed.
• Assist in the maintenance, calibration, and troubleshooting of laboratory instruments.
• Support contract testing coordination with third-party labs for specialized assays or confirmatory testing.
• Draft and revise SOPs, test methods, and other controlled documents.
• Work closely with the QC Supervisor/Quality Management to manage the workflow for raw material and finished good testing, ensuring timely completion and release.
• Participate in cross-functional meetings with QA, Production, and Purchasing to align testing priorities with business needs.
• Assist RM/FG CoAs approvals and releases materials/products as needed.
• Lead continuous improvement initiatives to enhance testing efficiency, reduce errors, and streamline processes.
• Engage in interdepartmental collaboration to resolve technical issues affecting RM/FG quality, including non-conformance investigations.
• Generates appropriate and complete finished product Certificates of Analysis per product requirement and verifying finished product CoA claims as accurate, true, and complete.
• Prepares sample, solvents/reagents, and systems for testing, calculates data and results, documents the entire procedure, disposes and safely cleans up solutions in the hazardous chemicals waste (under the hood), discards all disposables in appropriate waste containers and properly and safely cleans all glassware, work-stations, and apparatus/equipment used.
• Safely and appropriately uses tools such as scalpels, glassware, dishes, weighing dishes, pipets, burets, volumetric flasks, ovens, furnaces, stirrers/heat-plates, ultrasonicators, baths, balances, titrators, chemically resistant containers, graduated cylinders, beakers, spectrophotometer cuvettes and permanent markers.
• Ensure lab compliance with cGMP, safety, and environmental regulations, including proper chemical handling and waste disposal.
• Safely uses reagents (substance or compounds) such as water, acids and bases of varying concentration, buffers, and solvents ranging from weak to strong that are added to a system in order to bring about a chemical reaction or to see if a reaction, interaction, or separation occurs.
• Obtains sample and checks sample label and appearance to make sure that the sample is correct. Accurately weigh, label, log and document all samples and in-use apparatus, tools, equipment/instruments, and solvents/regents.
• Adheres to all safety, cGMP, and Captek's Standard Operating Procedures, particularly those of the 6 series, while par-taking in the accountability of all QC staff to do the same.
• Quality Control Chemist III must have the ability to be flexible, handle multiple projects simultaneously and adapt to increased business demands.
• Perform additional duties as assigned.

Qualifications:

• 5+ years of experience in a cGMP-regulated QC laboratory, with a focus on raw material and finished product testing.
• Proficient with advanced analytical instruments (HPLC, GC, UV-Vis, FTIR, AA) and method troubleshooting.
• Experience leading technical teams or mentoring junior chemists.
• Strong technical writing, problem-solving, and data analysis skills.
• Excellent communication skills, with the ability to work cross-functionally.
• Knowledge of regulatory requirements (21 CFR Part 111, USP, FDA) in dietary supplements or pharmaceutical industries is a plus.

Education/Experience:

Bachelor’s degree in Chemistry, Biochemistry, or related scientific field (required); Master’s degree preferred.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts, fumes, or airborne particles and risk of electrical shock. The noise level in the work environment is usually moderate.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Physical demands require sitting for extended periods of time, walking, bending, reaching, carrying, and occasionally lifting and/or moving objects up to 25 pounds. Specific vision abilities required by this job include Close vision, Peripheral vision, and the ability to adjust focus. While performing the duties of this job, the employee is occasionally required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear.

EEOC Statement:

CAPTEK is an equal employment opportunity employer. In order to provide equal opportunities to all individuals, employment decisions will be based on merit, qualifications, and abilities, not on any mental or physical disability. We comply with the law regarding reasonable accommodation for disabled employees and applicants.

We do not discriminate on the basis of actual or perceived race, color, national origin, ancestry, sex (which includes pregnancy, childbirth, breastfeeding and medical conditions related to pregnancy, childbirth or breastfeeding), reproductive health decisions, gender, gender identity, gender expression, religious creed, disability (mental and physical) including HIV and AIDS, medical condition (cancer and genetic characteristics ), genetic information, age, marital status, sexual orientation, military and veteran status, or any other characteristic protected by federal, state or local law. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.

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