Quality Control Chemist (FDA Regulated)

Element Staffing Services; South Carolina; On-site; USD 52,000 - 70,000; Full time

Job summary

Nutraceutical Manufacturing Company is seeking a Quality Control Chemist I to join our permanent, full-time team. The role focuses on release, stability, and test-method signaling for finished products and raw materials, following SOPs and compendial methods.

The ideal candidate has 0–5 years in a cGMP lab, hands-on experience with GC/LC instruments, and is adept at documentation and teamwork. Bachelor’s in Chemistry preferred; on-site work in a manufacturing environment.

Qualifications

• Bachelor of Science (B.S.) in Chemistry required.
• Experience in a cGMP environment preferred.
• Familiarity with regulatory guidelines (USP, FDA) and SOPs required.

Responsibilities

• Perform release, stability and special test method analyses per SOPs and compendial methods.
• Train on instrumentation operation and ensure proper calibration/maintenance.
• Maintain cGMP documentation and timely recordkeeping.
• Assist in OOS investigations and communicate with QC management as needed.
• Collaborate with QC team and other departments to support product quality.

Skills

HPLC operation

GC operation

LC method development

cGMP compliance

Documentation

Education

Bachelor of Science in Chemistry

Tools

Gas Chromatography (GC)

Liquid Chromatography (LC)

HPLC

FTIR

UV/Vis Spectrophotometer

Polarimeter

Dissolution Instrumentation

Disintegration Instrumentation

Laboratory Balances

Job description

This is a permanent, full-time, salaried position with an amazing nutraceutical manufacturing company! Apply today!

Roles and Responsibilities

• The Quality Control Chemist I (QCC) reports to Quality Control (QC) Management.
• Perform release, stability and special request testing of finished products and raw materials following Standard Operating Procedures (SOPs), in‑house test methods, and/or compendial methods.
• Train on the operation of the following instrumentation but not limited to: Laboratory Balances, High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Automated Titrators, FTIR, UV/Vis Spectrophotometer, Polarimeter, Dissolution and Disintegration Instrumentation. The operation of additional instrumentation and the need to train on new laboratory test methods when required.
• The QCC stays current on publications released by USP, FDA and other pertinent regulating bodies to ensure the Quality Control laboratory complies in the areas of analytical applications, release specifications, and documentation practices.
• The QCC assists QC management and/or designee in resolving Out of Specification (OOS) results in the QC Laboratory. Communicate effectively with QC management and with the Out‑of‑Specification/Trend Coordinator when suspect results are generated as well as with the Stability Coordinator when needed.
• The QCC assists in training new laboratory personnel and documents training in accordance with established laboratory SOPs and the company training program.
• The QCC follows Current Good Manufacturing Practice (cGMP) documentation guidelines to record all procedures in a timely fashion.
• Maintain a safe working environment and ensure that all equipment used in the testing procedures is calibrated and properly maintained.
• The QCC competes in specific projects assigned by management and other necessary functions.
• Perform other assigned duties as may be required in meeting company objectives.
• Communicate effectively with other departments within the organization and function within a team environment.
• Regular attendance is required.

Minimum Requirements

0 - 5 years of laboratory experience working in a cGMP environment preferred. Experience preferred with operation of laboratory instrumentation including Gas Chromatography (GC) and/or Liquid Chromatography (LC), troubleshooting, generation and revision of operating procedures and test methods. Effective interpersonal, self‑motivation skills, and the ability to interact with all levels of personnel are required.

Education and Experience

A Bachelor of Science (B.S.) or Bachelor of Arts (B.A.) degree in Chemistry