Compliance Team, Inc.

  • Compliance Auditor II – Internal Audits

    Job Locations US-MO-St. Louis
    Posted Date 3 weeks ago(4/5/2018 1:56 PM)
    ID
    2018-1218
    # of Openings
    2
    Category
    Compliance
  • Overview

    Compliance Team, Inc. is a leading provider of technical consulting services to our clients in the pharmaceutical, biotechnology, and medical device industries in the areas of commissioning, qualification, validation and regulatory compliance.  We are proud of our talented professionals and the major contributions they make to our clients’ successes on mission critical projects.

     

    This position is responsible for interpreting the GMP regulations / guidelines ensuring that the site remains compliant with these requirements. Compliance Auditor II will ensure realization of the site audit plan by conducting internal audits and inspections and ensuring the follow-up on corrective actions. Compliance Auditor II will report findings in a clear, precise and factual way. Responsible for suggesting and evaluating changes to the site’s quality system. Work closely with departments outside QA to improve overall quality and make sure that site personnel are properly trained / qualified to perform their assigned duties. Compliance Auditor II will contribute to the continuous improvement of the internal processes and may be asked to participate in Quality related Project teams.

    Responsibilities

    • Perform internal audit, write audit reports, and follow-up on audit responses and corrective actions.
    • Remain up-to-date on current Regulatory trends (Regulatory Observations, New Regulations/Guidelines) as well as Quality Standards.
    • Follow up of action items generated from internal Audit & Walkthrough audits.
    • Perform site specific supplier audits as needed.
    • Other duties within the quality department as required.

     

    Qualifications

    • Bachelor's degree in a technical field i.e. Biology, Chemistry, Engineering, Pharmacy and a minimum of four years related experience or equivalent combination of education and experience.
    • Minimum three years of experience in a pharmaceutical production, medical device, and/or combination product environment.
    • Experienced in auditing with GMP regulated industries required.
    • Knowledge of Quality Systems in pharmaceutical, medical device, or combination product industry.
    • ASQ Certified Quality Auditor is preferred.
    • Experience in aseptic manufacturing is preferable.
    • Fluent in English both speaking & writing
    • Good knowledge of MS Office

    In addition to the above technical competencies, ideal candidates will have a commitment to deliver quality documents and service. Candidates must be results-oriented, able to make decisions and able to prioritize work per business needs.  The successful candidate will demonstrate integrity, reliability, dedication, adaptability, innovation, and self-motivation.

     



    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed