Chemist I
: Job Details :

Job Summary:The Analytical Chemist I will provide 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, will be responsible for managing 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 US Food and Drug Administration. Job Responsibilities:Draft and review technical documents supporting raw material and/or drug product release and stability with some supervisionPerform calibrations and calibration verificationCompile data to support trending analysisPerform 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 techniquesPerform instrument troubleshooting and preventive maintenance as neededPerform 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 neededPerform all activities in compliance with cGLP/cGMP requirementsPerform all activities in compliance with SOP requirements This position may be involved with the transportation and handling of hazardous waste; basic RCRA training is required for all employees within 1 year of hire, and annually thereafterAssume other responsibilities as assigned by area managementPerform other duties as assignedRequired Skills:Requires attention to detail Requires good verbal and written communication, organization, time-management, display sound judgment, problem-solving, interpersonal and analytical skillsEducation and Experience Requirements:Associate degree (or better) with four (4) years Chemistry experience required Some working knowledge of FDA Regulations/Guidance's, Good Laboratory Practices, Good Manufacturing Practices, and ICH Guidelines, USP/NFTwo (2) years' experience working in a laboratory setting Two (2) years working with Empower and HPLC'sPharmaceutical experience desired