Job Description

Position Summary:

The Analytical Chemist II will perform analytical testing to support ongoing product release, raw material release and stability studies as needed, generate, and review technical documents that support raw material and product release and stability under minimal supervision, and will be responsible for managing their activities with good time management to maximize productivity. This position supports the ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory requirements of the U.S. Food and Drug Administration.

Job Responsibilities:

• 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, etc
• Perform instrument troubleshooting and preventive maintenance with guidance from laboratory leadership as needed
• Perform calibrations and calibration verifications
• Compile data to support trending analysis
• Write, review, and update standard operating procedures and department policies as needed
• Draft and review technical documents supporting raw material and/or drug product release and stability with some supervision
• Perform all activities in compliance with cGLP/cGMP requirements
• Assume other responsibilities as assigned by area management
• Complete basic RCRA training within 1 year of hire and annually thereafter
• Perform other duties as assigned

Required Skills:

• Must have good verbal and written communication, organization, time-management, display sound judgment, problem-solving, interpersonal and analytical skills

Education and Experience Requirements:

• Bachelor's degree in chemistry or related scientific discipline with 1 year of relevant laboratory experience; or an Associate's degree with approximately 2 years of relevant industry experience
• 1-4 years of laboratory experience

Job Tags

Local area,

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