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Cincinnati

    clinical and health - Cincinnati, OH, United States - Cogent Infotech Corporation

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    Description
    Job Description:

    Position Summary:
    • The Quality Control Scientist I performs routine analyses and documentation of any of the following: In-Process and Finished Product samples for pharmaceutical batch Release, Stability samples or Projects within the QC Chemistry Laboratory, in a manner consistent with established standards.

    • Supports internal development and/or manufacturing operations.

    • Makes detailed observations & reviews, documents, and communicates test results.


    Job Functions:
    • Conducts routine chemical testing of finished products, and stability samples by internally developed and compendial test methods.

    • Performs validated test methods for pharmaceutical finished products for strength, impurities, identity, and characteristics by using HPLC and wet chemistry techniques.

    • Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems efficiently.

    • Performs daily instrument calibrations/verifications as required.

    • Clearly and accurately communicates the results of work by accurate documentation of the testing/analysis & acquired results.

    • Records and reports results of analysis in accordance with prescribed lab procedures & systems.

    • Prepares test solutions including diluents and mobile phases.

    • Cleans and maintains work area & instrumentation

    • Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.

    • Maintains vital compliance status required by company and facility standards.


    Education/Experience:
    • Bachelor's degree, or greater, in physical science, preferably in Chemistry.

    • 1-2 years of experience performing chemical tests with chromatographic technique is preferred.

    • Working theoretical knowledge of HPLC is required as well as practical execution.

    • Equivalent combinations of education, training, & meaningful work experience may be considered.


    Knowledge/Skills/Abilites:
    • Good knowledge & understanding of basic instrumental technologies and qualitative & quantitative chemical analyses.

    • Awareness of quality & regulatory requirements in the pharmaceutical industry.

    • Good problem-solving skills and logical approach to solving scientific problems.

    • Follow all company policies, SOPs, cGMPs, work instructions, methods & analyst guidelines.

    • Demonstrates efficiency by multitasking and scheduling time to meet required workload.

    • Actively seek additional assignments when testing in primary area of responsibility is completed.

    • Takes initiative and independently pursues training and/or learning opportunities to improve personal skills and share skills with other team members.

    • Shown interpersonal and communication skills (both oral & written).

    • Ability to apply mathematical operations to such tasks as determination of test reliability, analysis of variance, and correlation techniques.

    • Ability to work in a fast-paced environment.


    Physical Requirements:
    • Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.


    Use of:
    • Safety glasses

    • Safety shoes

    • Lab coat

    • Latex or similar gloves

    • Safety apron

    • Organic respirator occasionally (i.e. Surge 100)


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