Senior Chemist – Quality Control

Key Responsibilities:

• Complies with all cGLP/GMP and safety requirements, laboratory SOPs, and Company policies.

• Ensures compliance with good housekeeping and laboratory safety practices.

• Performs advanced chemical analysis and testing of raw materials, in-process samples, finished products, and stability samples.

• Operates, calibrates, troubleshoots, and maintains analytical instrumentation including HPLC, GC, ICP, UV-Vis, FTIR, titrators, and dissolution equipment.

• Reviews and approves laboratory data, calculations, and analytical documentation to ensure accuracy and compliance.

• Performs method validation, method transfer, verification, and analytical troubleshooting.

• Investigates Out of Specification (OOS), Out of Trend (OOT), deviations, and laboratory non-conformances.

• Prepares sample solutions, reagents, standards, and volumetric solutions according to SOPs and cGMP requirements.

• Maintains appropriate documentation, laboratory notebooks, and records in compliance with cGLP and cGMP standards.

• Supports internal and external audits, FDA inspections, and regulatory compliance activities.

• Assists in the development and revision of SOPs, specifications, test methods, and laboratory procedures.

• Trains and mentors QC Chemists, Laboratory Technicians, and junior staff.

• Coordinates laboratory activities and assists management with scheduling and workload prioritization.

• Maintains inventory control of laboratory supplies, chemicals, standards, and reagents.

• Ensures proper disposal of hazardous waste according to EPA regulations.

• Performs related duties as assigned by management.

Qualifications:

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific field required.

• Minimum of 5+ years of experience in a pharmaceutical, nutraceutical, food, or regulated laboratory environment.

• Strong knowledge of cGMP, cGLP, FDA regulations, and laboratory safety practices.

• Experience with analytical instrumentation such as HPLC, GC, ICP, UV, FTIR, and titrators.

• Experience performing analytical method validation and troubleshooting.

• Strong documentation, investigation, and technical writing skills.

• Bilingual (English and Spanish) preferred.

• Strong mathematical, analytical, and problem-solving skills.

• Ability to work independently and in a fast-paced environment.

• Leadership and mentoring experience preferred.

Other Requirements:

• Must be available Monday to Friday from 8:00 AM to 4:30 PM.

• Ability to occasionally lift up to 50 pounds.

Physical Requirements:

• Requires standing, bending, lifting, handling chemicals, and prolonged computer use.

Work Environment:

• Works frequently in a laboratory and manufacturing environment.

• Exposure to chemicals, laboratory equipment, and regulated production areas.