Compliance Team, Inc.

  • Vendor Quality Auditor

    Job Locations US-MO-St. Louis
    Posted Date 1 month ago(4/26/2018 12:23 PM)
    ID
    2018-1221
    # of Openings
    1
    Category
    Quality
  • 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.

     

    We are searching for a Vendor Quality Auditor for one of our clients in Westport, MO.

    This position is responsible for interpreting the GMP regulations / guidelines and ensuring that the site remains compliant with these requirements.  Responsible for the Lead Site Pest Control Program, Vendor Quality Auditor will ensure realization of the site audit plan by conducting internal audits and inspections and ensuring the follow-up on corrective actions. Vendor Quality Auditor will report your findings in a clear, precise and factual way. In this role you are responsible for suggesting and evaluating changes to the site’s quality system. Will 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. Vendor Quality Auditor II will contribute to the continuous improvement of the internal processes and may be asked to participate in Quality related Project teams.

    Responsibilities

    • Manage Internal Audits and the site Quality Assurance Self-Assessment (QASA) program to include scheduling, mentoring auditors, approving QASA reports etc.Lead preparation and/or facilitation of regulatory/customer inspections
    • Management/oversight of the site Pest Control Program
    • Coordinate mock audits
    • Ensures processes associated with sustaining an inspection readiness state are maintained, including but not limited to: Maintain Site Regulatory Inspection Plan, Develop and Provide Inspection Readiness Training, Ensure individuals are trained in inspection readiness process, provides clear understanding of roles and responsibilities to sustain an inspection readiness state
    • Remain up-to-date on current Regulatory trends (Regulatory Observations, New Regulations/Guidelines) as well as Meridian Medical Technology Quality Standards. Communicate to the network key learnings at any of our sites through a regulatory audit or emerging regulations.  Input could be from our own network (inspections, complaints, internal audits) or from external regulatory intelligence (WLs from other companies, emerging regulations).
    • Oversee regulatory commitments and health authority queries. Assist with draft responses to audit observations
    • Incorporate CAPA effectiveness and Change Control information into Inspection Readiness Program
    • Lead Site Pest Control Program
    • Perform site specific supplier audits as needed
    • Follow up of action items generated from internal Audit & QASA.
    • Work with Pfizer Global Supply groups (center functions, other sites) 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 environment
    • Experienced in auditing with GMP regulated industries required.
    • Experience with preparation and/or facilitation of regulatory inspections (FDA, EMA, etc.) required
    • Knowledge of Quality Systems in pharmaceutical industry
    • ASQ Certified Quality Auditor is preferred
    • Experience in aseptic manufacturing is preferable
    • Excellent written and verbal communication skills
    • Expert skills in document manipulation and electronic document maintenance (e.g. Word, Excel, PowerPoint, SharePoint, Adobe Acrobat) and other data man

     

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