• Quality Control Analyst II

    Abeona (Cleveland, OH)


    Job Title Quality CONTROL Analyst II

     

    Department Quality and Compliance

     

    Reports to Supervisor or Manager, Quality Control

    DESCRIPTION

    Position Overview

    The Quality Control Analyst II 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. Supports the authorship and revision of GMP documentation. 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.

    + Conduct training of new hires using Abeona’s On-the-Job-Training (OJT) aides.

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

    + Author and revise existing Standard Operating Procedures (SOPs), testing forms and product specifications (SPCs).

    + 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 organized manner, in compliance with company documentation practices (GDP).

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

    + Supports laboratory investigations related to test failures, discrepancies and deviations.

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

    + Performs visual inspection of drug product at Qualified Treatment Centers (QTCs)

    + Performs other duties as assigned by management.

    Qualifications

    + BS in biochemistry, biology, microbiology, molecular biology or other relevant discipline with 3 to 5 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 preferred.

    + 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

    + Frequent weekend work/travel may be required.

    + Frequent travel (up to 50%) to perform visual inspection at QTCs.

    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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