Quality Control Chemist - Days

Job overview

Testing and compliance

• Performs chemical analyses for raw materials, in-process materials, intermediates, finished goods, and stability samples.
• Follows EPA, FDA, cGMP, cGLP, DEA, OSHA, and company safety rules, regulations, and procedures.
• Reviews and enters data and evaluates test-result validity.
• Performs in-depth investigations of non-complying test results.

Laboratory programs and methods

• Maintains and supports calibration, preventive maintenance, and IQ/OQ/PQ programs.
• Troubleshoots equipment and performs and documents method transfers from Analytical Development.
• Runs method evaluation experiments and writes controlled documents such as reports, test procedures, and SOPs.
• Maintains laboratory solutions, inventory, and notebooks.

Team and work coordination

• Provides off-shift coverage as required and assists with employee training inside and outside the department.
• Coordinates and communicates project status, interacts with outside vendors and other departments, and acts as a departmental subject matter expert.
• Handles, analyzes, and disposes of hazardous samples and waste.

Education and experience

• Required: BS/BA in Chemistry, Biology, or a related science field.
• Strong cGMP experience and experience testing against USP and EP compendia are required.
• Three years of laboratory cGMP experience is preferred, with a preference for at least five years for applicants with a bachelor's or advanced degree.
• Preferred: Advanced degree in Chemistry, Biology, or a related science field.

Technical qualifications

• Requires working knowledge of analytical instrumentation, including GC and HPLC at minimum, and strong chemistry theory.
• Working knowledge of NMR, DSC, ion chromatography, and/or ICP-OES is preferred.
• Mass spectrometer experience is preferred.
• Requires attention to detail, effective oral and written communication, teamwork, and the ability to work independently with little supervision.

Schedule

• The job title identifies a day shift; off-shift coverage may be required.

Workplace conditions

• The work is performed in a chemical production and laboratory setting and may involve handling hazardous samples and waste.

About Cambrex