Job Responsibilities

• Draft and review technical documents supporting raw material and/or drug product release and stability with some supervision.
• Perform calibrations and calibration verifications.
• Compile data to support trending analysis.
• Perform analytical testing of samples supporting incoming raw materials, in-process production, drug product and stability samples with some supervision.
• Utilize analytical instrumentation such as FTIR, HPLC, GC, AA, wet chemistry techniques, UV/VIS, KF, and Polarimeter, and has a good scientific understanding of these techniques.
• Perform instrument troubleshooting and preventive maintenance as needed.
• Perform investigations on studies that have unusual results, and on out-of-trend and out-of-specification results.
• Write, review, and update standard operating procedures and department policies as needed.
• Perform all activities in compliance with cGLP/cGMP requirements.
• Assume other responsibilities as assigned by area management.
• This position may be involved with the transportation and handling of hazardous waste.
• May handle hazardous waste as required to dispose of laboratory solutions. Basic RCRA training is required for all employees of the laboratory and continuing RCRA training will be performed on an annual basis. New hires may only handle hazardous waste prior to attending RCRA training if they are under the supervision of a RCRA trained employee. RCRA training will be attended within six (6) months of hire.

Experience Requirements

• Good attention to detail and some working knowledge of FDA Regulations/Guidance’s, Good Laboratory Practices, Good Manufacturing Practices, and ICH Guidelines, USP/NF.
• Good verbal and written communication, organization, time-management, display sound judgment, problem-solving, interpersonal and analytical skills.
• Familiarity with Empower

Education Requirements

• *Bachelor’s degree in Chemistry or related scientific discipline with approximately 0 - 1 year of relevant Analytical Chemistry experience or an Associate’s degree with approximately 2 – 4 years Analytical Chemistry or a lesser degree with more than 5 years’ experience; preferably in QC, in the pharmaceutical industry.

Job Type: Full-time

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