Compliance Auditor Vendor

US$65 - US$90 per annum
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. United States
Jefferson City, Missouri
Posting date: 01 Feb 2019
QA.KM.21521_1549021250

ProClinical is pleased to advertise an exciting vacancy for a Compliance Auditor Vendor to join a medical technology company that is committed to defend against time-sensitive situations by providing medical countermeasures to more than 30 countries around the world.

Located in Missouri, the Compliance Auditor Vendor will provide hands on support for vendor management systems, including completing vendor risk assessments, creating vendor management SOPs, reviewing and approving vendor surveys and remote audits. The incumbent will report findings in a clear, precise and factual way. In this role the contractor is expected to provide expertise, along with suggestions and evaluations regarding changes to the vendor management system.

Job Responsibilities:

  • Writing clear, concise SOPs on vendor management.
  • Reviewing and approving vendor surveys.
  • Reviewing vendor master files and ensuring that documents are sufficient for vendor qualifications and oversight.
  • Developing vendor management tools and templates for implementation at the site.
  • Writing risk assessments for vendors.
  • Aiding implementation of vendor oversight activities.
  • Writing and reviewing vendor audit reports.
  • Approving vendor audit reports and questionnaires.
  • Compiling and analysing metrics and vendor KPIs.
  • Performing desktop and onsite audits (this will be minimal).

Skills and Requirements:

  • A minimum of 10 years of experience in a pharmaceutical, medical, and/or combination product production environment.
  • Experience in auditing with GMP regulated industries required.
  • Experience with preparation and/or facilitation of regulatory inspection (FDA, EMA, etc) required.
  • ASQ Certified Quality Auditor is preferred.
  • Demonstrable experience in vendor oversight and risk assessments preferred.
  • Excellent communication, presentation, persuasion, and client facing skills.
  • Excellent English written and oral skills.
  • Experience working in a consulting environment preferred.
  • Expert skills in document manipulation and electronic document maintenance, such as Word, Excel, PowerPoints, SharePoint, Adobe Acrobat, and any other data management tools.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Keri Marshall on +44 207 440 0679 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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