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.