Vacancy Details

Back to Jobs...

Ref: GCP QA//MM

GCP Auditor

Mackenzie Stuart is working in close partnership with a fast-growth Clinical Research Organisation with extensive clinical trial experience and operational excellence in a wide range of therapeutic areas.

Our client is actively recruiting a GCP Auditor – US based. This individual will be responsible for conducting audits and providing quality solutions to both internal and external customers whilst building and maintaining effective working relationships throughout the company.

Responsibilities

  • Travel locally and across North America locations where sites are located as needed.
  • Maintain knowledge of ICH GCP principles
  • Lead/assist audit activities, inc. investigator site, key document, and sponsor audits
  • Follow audit activities from plan to closure
  • Support regulatory inspections onsite or remotely
  • Maintain quality tracking documents
  • Train new staff as required
  • Provide presentations on GCP topics, quality trends, continuous improvement activities
  • Assist with oversight of contract auditor assignments

Qualifications

  • Knowledge of ICH Good Clinical Practice guidelines
  • Understanding of clinical research regulations
  • Minimum of 3 years’ experience as GCP Auditor in Clinical QA
  • BS/BA Scientific/Healthcare related field
  • Experience of risk identification and employment of mitigation strategies
  • Required certification preferable; (SQA RQAP-GCP, ASQ Certified Quality Auditor)
  • Excellent interpersonal communication skills
  • Knowledge with GCPs and international and local regulations related to clinical trials
  • Ability to work independently and as a team
  • Practical ability in applying proactive quality approaches for clinical trials
  • Experience with clinical study/quality electronic systems

About Mackenzie Stuart Global Executive Search & Selection:
Mackenzie Stuart is a leading executive search and selection business. From our offices in Leeds, London & Toronto we provide retained and contingency recruitment solutions across industry and have specialist recruitment consultants that work within the Oil & Gas, Mining, Infrastructure & Built Environment, Medical & Scientific, Healthcare, Education, Finance & Accountancy, Insurance, Water, Chemicals & Coatings, Ingredients & Flavours, Automation, FMCG and Logistics sectors.

Job Reference: GCP QA//MM

Apply Now

Apply Now

Name

Email (required)

Tel Number

Attach CV

By clicking “Apply Now” you are agreeing to Mackenzie Stuart reviewing your CV and for one of our Consultants to contact you to discuss your application in more detail. Please note if you are unsuccessful for this position, your CV will be removed from our database within 6 months of receipt. If you wish to apply for more than one position, please attach your CV to each application. To know more about what we will do with your personal data, please read our Privacy Policy.

Salary Range

$80,000 - 120,000

Location

United States