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Exton

    Quality Control Lab Tech - Exton, United States - Beacon Hill

    Beacon Hill
    Beacon Hill Exton, United States

    4 days ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    General Responsibilities:

    The QC Support Clerk will perform a variety of tasks in support of daily quality control responsibilities. Adherence to Good Manufacturing Practices (cGMP) and Good Documentation Practices are mandatory.

    Responsibilities:


    • Perform daily lab cleaning and disinfection tasks.


    • Ability to follow standard operating procedure documentation.


    • Provide support for quality control activities including but not limited to the following: material inventory review, kit and material preparation, equipment maintenance review, document organization and filing, spreadsheet (Excel) updating.


    • Ensure adequate inventory of supplies and raw materials are stocked in the controlled and supporting areas.


    • Records, enters, and verifies data appropriately in relevant documentation and databases in a clear and concise manner per Good Documentation Practices (GDP).


    • Assists with warehouse management, critical reagents inventory and the maintenance of material inventory logs.


    • Completes and documents all applicable training in a timely fashion; ensures training status remains in good standing.


    • Assists in the completion of action items and necessary tasks to aid in the closure of outstanding quality items (i.e. deviations, investigations, change controls, etc.).


    • Identifies and escalates atypical observations or issues to area management in real time.

    Computer Skills:


    • To perform this job successfully, an individual should have knowledge of Database software, Spreadsheet software and Word Processing software.

    Education:


    • High School Diploma, or equivalent

    Experience:


    • Minimum of 1+ years' relevant industry experience.


    • Familiar with 21 CFR Part 11, standard GxP best practices and FDA regulations.


    • Excellent verbal and written skills.


    • Good interpersonal communication skills.


    • Must be willing to work weekends, evenings, and holidays (as needed).

    Physical Demands:

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


    • While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand, walk, sit, use hands and fingers to handle equipment or feel and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

    Work Environment:

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


    • Ability to complete tasks within a controlled environment.


    • The noise level in the work environment is usually moderate.

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