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    Quality Technician - Phoenix, United States - Staffmark Group

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    Description
    Advantage Technical is seeking a Quality Technician - Microbiology for our large pharmaceutical client in Phoenix, AZ. This is a 2nd shift position (3:30pm to 12am). This is a great opportunity to gain valuable experience at a fantastic company Do you have what it takes?


    Position Summary:


    Ensure and assist with site-specific quality compliance according to our client's (SOPs) & specifications, quality review of documents, label control, assist with release activities and product inspections.


    Essential Duties/Responsibilities:

    • Perform product inspection for defects, leaks and particulates.
    • Perform environmental monitoring of personnel (as needed) and complete documentation.
    • Assist in the media fill process validations to include inspection of filled units
    • Perform document review of compounding activities such as cleaning records, line clearance forms and inventory sheets: o Verify that raw materials meet specification
    o Verify and account for labeling

    o Review temperature and BMS alarms

    o Verify that product test results meet specification limits

    o Verify that all documentation is complete

    o Document non-compliance and work with supervisor/lead if further investigation is needed


    • Submit samples to the appropriate lab for particulate identification or microbial analysis.
    • Assist with equipment calibration program and maintenance record files.
    • Assist with raw material release and movement.
    • Under the direction of supervisor/lead, document and initiate quality events for deviation and complaint investigations.
    • Support internal & external audits.
    • Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.).
    • Participate in Quality Manager's staff meetings

    Expertise:
    Knowledge & Skills


    • Knowledge of pharmacy operations and regulatory guidelines.
    • Ability to perform calculations.
    • Ability to work within established procedures and practices
    • Strong organizational skills and attention to detail
    • Ability to effectively troubleshoot issues.

    Required:

    • Minimum of High School Diploma/GED with work experience
    • Minimum of 2 years experience in a quality or manufacturing department of a pharmaceutical, Medical Device or Allied Health Science.

    Desired:

    • Experienced in aseptic operations.
    • Experience within a regulated environment
    • Associates Degree or higher level degree in Technician technical scientific discipline, Biology, Microbiology, Chemistry or Pharmacy.


    After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities.

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