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QC Operations Specialist

Company: ADMA Biologics
Location: Boca Raton
Posted on: November 25, 2022

Job Description:

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Quality Control Operations Specialist! The QC Operations Specialist will provide operational support to all QC testing and processing areas regarding, but not limited to, monitoring QC projects, quality oversight and quality system records, data management, and SME support for LabVantage LIMSQualifications

  • QC Projects
    • Assist in tracking QC projects and work with QC management and project owners to ensure timelines are met.
    • Provide project update to QC management
      • Quality oversight and quality systems
        • Data Integrity oversight of laboratory instrumentation usage
        • Track open quality systems records and QC assist areas to meet deadlines
        • Organize routine interdepartmental meetings, provide agendas, and write meeting minutes
        • Perform data analyses and identify opportunities for operational efficiencies
        • Perform QC tests and data review
        • Provide technical support to all QC areas upon request
          • Data management:
            • Use tools like Excel to manage large sets of information and produce clear, concise summaries based on target audience needs.
            • Perform basic database searches
            • Support data QC trending and analysis
              • SME support for LabVantage LIMS
                • Become an area SME for LabVantage LIMS
                • Support training and write work instruction for new LIMS functionalities
                • Perform troubleshooting of user data issues
                • Assist in communications between QC and Data Integrity (IT) teams Education Requirements: At a minimum, Bachelor's Degree in Chemistry, Microbiology, Biochemistry or a related scientific discipline. Experience Requirements: A minimum of 1 year working experience in a quality department of a pharmaceutical or biopharmaceutical GMP facility. Knowledge of cGMP requirements is essential. Knowledge of ICH, GAMP, and industry guidance is also essential. In addition to competitive compensation, we offer a comprehensive benefits package including:
                  • 401K plan with employer match and immediate vesting
                  • Medical, Vision, Life and Dental Insurance
                  • Pet Insurance
                  • Company paid STD and LTD
                  • Company Paid Holidays
                  • 3 Weeks' Paid Time Off (within the first year)
                  • Tuition Assistance (after the first year)
                  • Easily accessible to Tri-Rail
                  • Shuttle to the Boca Tri-Rail station ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit . ADMA Biologics is an Equal Opportunity Employer

Keywords: ADMA Biologics, Boca Raton , QC Operations Specialist, Other , Boca Raton, Florida

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