Chemist, Quality Control
US Pharma Lab
Job Title: Chemist, Quality Control
Role Overview
The Chemist, QC performs analytical testing, laboratory investigations, data review, and quality control activities to ensure the identity, strength, purity, and quality of raw materials, active pharmaceutical ingredients (APIs), in-process materials, finished products, and stability samples. This role operates within an FDA-regulated laboratory environment and supports compliance with cGMP, Good Documentation Practices, company procedures, and applicable regulatory requirements. The Chemist performs chemical and physical analysis using various techniques and instrumentation, including HPLC/UPLC, GC, ICP-MS, UV-Visible Spectrophotometer, FTIR, Auto Titrators, Dissolution Apparatus, Karl Fischer Titrators, Bulk Density Testing, Potentiometers, and other QC laboratory equipment. The role is responsible for accurate testing, documentation, instrument operation, troubleshooting, and communication of analytical results to support product quality and timely release. Across all levels, the Chemist is expected to demonstrate strong analytical skills, attention to detail, problem-solving ability, and commitment to quality and compliance. Career progression involves executing established procedures at the entry level to independently managing complex analytical challenges, supporting method validation/verification, compendial compliance, and providing technical leadership within the QC organization.
Key Responsibilities
- Perform routine sampling, chemical testing, physical testing, and assays of raw materials, active pharmaceutical ingredients (APIs), in-process materials, finished products, and stability samples in an FDA-regulated laboratory environment.
- Perform analytical testing using wet chemistry techniques and laboratory instrumentation.
- Prepare reagents, standards, solutions, and samples according to approved procedures.
- Perform assigned testing activities and accurately document analytical results.
- Support troubleshooting and testing of specific batches to assist with identification of potential causes of out-of-specification (OOS) results.
- Assist with customer complaint investigations by providing analytical test results.
- Prepare and review QC documentation, including test records, SOPs, test procedures, and protocols as assigned.
- Perform routine instrument maintenance and calibration activities under supervision and training.
- Maintain laboratory organization, housekeeping, safety, and chemical waste compliance.
- Follow cGMP, Good Documentation Practices, and company quality requirements.
- Work extended hours or occasional weekends as required.
- Perform other duties as assigned.
Requirements & Tech Stack
- Analytical Techniques: Wet chemistry, HPLC/UPLC, GC, IR/FTIR, UV-Visible Spectrophotometer, Dissolution Apparatus, Karl Fischer (KF), Auto Titrator, Potentiometer, Bulk Density Testing.
- Laboratory Equipment: ICP-MS, Other QC laboratory equipment.
- Software: Experience with chromatography software preferred (e.g., LabSolutions, Waters Empower).
- Compliance: cGMP, Good Documentation Practices, 21 CFR Part 11.
- Tools: Microsoft Word, Excel.
Qualifications
Chemist, QC I
- 0–2 years laboratory experience.
- Entry-level analytical laboratory experience preferred.
- Ability to follow procedures and accurately perform laboratory testing.
- Strong attention to detail and documentation skills.
- Ability to work effectively within a team environment.
- Basic knowledge of cGMP, and Good Documentation Practices.
Chemist, QC II
- 2–5 years QC laboratory experience.
- Experience in dietary supplements, food, OTC, pharmaceutical, or regulated manufacturing preferred.
- Ability to independently perform analytical testing and troubleshoot issues.
- Strong understanding of cGMP, and 21 CFR Part 11 requirements.
- Ability to prepare clear technical reports and documentation.
- Strong problem-solving and time-management skills.
- Ability to support continuous improvement activities.
- Experience with chromatography software preferred.
Chemist, QC III
- 5+ years progressive QC laboratory experience.
- Experience in dietary supplements, food, OTC, pharmaceutical, or regulated manufacturing preferred.
- Demonstrated technical expertise in analytical testing, troubleshooting, and investigations, validation/verification.
- Advanced analytical troubleshooting skills.
- Strong technical writing and investigation skills.
- Ability to mentor and train laboratory personnel.
- Strong understanding of quality systems and regulatory expectations.
- Ability to lead technical projects and improvements.
General Education & Qualifications
- Bachelor’s degree in chemistry or related scientific discipline required.
- One year of basic chemistry laboratory experience (academic experience acceptable) preferred.
Physical Requirements
- Approximately 80–100% of work in a laboratory environment.
- Frequently performs bench-level activities while standing or sitting.
- Uses hands for laboratory operations, equipment operation, and handling materials.
- May require bending, squatting, kneeling, walking short distances, and working around laboratory equipment.
- Must be able to wear required PPE, including: Lab coat, Gloves, Safety glasses/goggles, Face mask, Booties, Respiratory protection when required.
- May occasionally lift up to 35 lbs.
- Ability to work in laboratory, office, and manufacturing environments.
Work Environment
- Approximately 80% of work performed in a laboratory environment.
- Exposure may include chemicals, cleaning agents, odors, dust, noise, and laboratory fumes.
- Work environment may include moderate temperatures and controlled laboratory conditions.