Compliance Team, Inc.

  • Quality Investigator - Aseptic Manufacturing

    Job Locations US-MO-St. Louis
    Posted Date 3 weeks ago(7/24/2018 10:29 AM)
    # of Openings
  • Overview

    Compliance Team, Inc. is a leading provider of quality technical consulting services and resources to our strategic partners in the pharmaceutical, biotechnology, and medical device industries. Whether we are asked to provide an entire team or an individual, our professionals consistently provide Quality oversight of operations and data review for accuracy, completeness, and conformance to current good manufacturing practices (cGMP), company quality standards, and regulatory compliance. We are proud of our talented professionals and the major contributions they make to our clients’ successes on mission critical projects.


    Compliance Team has a variety of challenging opportunities for top-notch quality investigators with strong skills and expertise in Aseptic Manufacturing and Microbiology to support our regulatory compliance consulting contracts with a loyal client in St. Louis, Missouri. As a Compliance Team consultant, you must have top-notch experience investigating sterility failures in aseptic operations, with microbiology laboratory experience in the pharmaceutical or medical device industry.



    Responsibilities include the following tasks:

    • Investigate, write, and close out root cause investigations and CAPAs, following corporate procedures, FDA, and GMP guidelines, completing investigations within a 30-day timeframe.
    • Implement necessary follow-up verification checks on investigations and CAPA action items.
    • Coach company colleagues in order to facilitate focused knowledge transfer for quality investigations.
    • Perform SOP reviews to assist with process improvements and future revisions in a timely manner throughout the term of the project.
    • Participate in investigation-related meetings.
    • Analyze CAPA effectiveness through appropriate tracking/trending to prevent recurrurence.
    • Prepare daily and weekly reports for Management.



     The following are Minimum qualifications for the role:

    • Bachelor degree in Biology, Microbiology, Engineering, Science, or related field

    • 4+ years additional significant microbiology experience and education in a pharmaceutical environment 

    • 7+ years of GMP Pharmaceutical experience performing investigations, with 7+ years of CAPA experience.
    • 4+ years of root cause investigation experience in an aseptic manufacturing environment
    • 15+ years demonstrated problem solving skills

    The following are qualifications of our top candidates:

    Experience performing quality investigations for Combination Products

    Experience performing quality investigations in an FDA Remediation setting

    Experience applying cGMP in both the U.S. and ex-U.S.

    Experience working in a Manufacturing setting and with serving as a cross-departmental liaison

    Experience consulting in the field of FDA Compliance and GMPs.



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