• Analyst Quality Control Micro Analytical

    Abeona (Cleveland, OH)


    DESCRIPTION

    POSITION OVERVIEW

    The Quality Control Analyst I performs routine laboratory activities in support of Good

     

    Manufacturing Practices (GMP) testing for Quality Control (QC). Performs in-process and release

     

    testing for drug substance and drug product. Interacts with employees internal and external to

     

    Quality Control.

     

    Essential Duties and Responsibilities

     

    + Works on QC tasks of diverse scope, requiring basic knowledge of laboratory concepts.

    + Train on applicable Standard Operating Procedures (SOPs) and Methods.

    + Perform endotoxin, gram stain, bioburden, rapid sterility testing, and visual inspection of the drug product and drug substance using standard techniques in biochemistry, molecular biology and cell biology, and according to approved test methods.

    + Proactively communicates laboratory issues to supervisor or manager. Initiates laboratory investigations related to test failures, discrepancies and deviations.

    + Completes laboratory work with precision and maintains hardcopy paperwork and electronic data in an organized manner, in compliance with company documentation practices (GDP).

    + Provides input to improving QC systems and procedures to improve GMP compliance.

    + Helps maintain the laboratories in a GMP compliant state, including participating in cleaning, instrument routine and preventative maintenance, logbook usage and review, etc.

    + Performs other duties as assigned by management.

    Qualifications

    + BS in biochemistry, biology, microbiology, molecular biology or other relevant discipline with 1 to 3 years of relevant experience.

    + Experience and knowledge in the pharmaceutical and/or biotech industry within a GMP and/or GLP environments preferred.

    + Experience in microbiological assays.

    + Understanding of basic scientific concepts in one or more areas above.

    + Experience with relevant analytical lab equipment and computers preferred.

    + Good mathematical and organizational skills

    + Ability to interact constructively with co-workers to solve problems and complete tasks

    + Some weekend work or late nights may be required periodically.

    + Occasional travel (less than 20%) to train on visual inspection of the drug product.

     

    Physical Demands

     

    + A normal range of hearing and vision correctable to 20/20, and Occasional lifting up to 25 pounds is required.

     

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