Clinical QA Auditor

Highly Competitive Salary
  1. Permanent
  2. Clinical Trial Assistant (CTA), Clinical Evaluation
  3. United States
Redwood City, USA
Posting date: 19 Nov 2020
CR.CN.34250

Proclinical is currently recruiting for a Clinical QA Auditor with a pharmaceutical company located in Redwood City, CA.

Job Responsibilities:

  • Preparing and conducting audits.
  • Responsible for the Quality Assurance (QA) aspects of clinical trials, ensuring trials conform, to ICH-GCP and Standard Operating Procedures (SOPs).
  • Conduct document CAPA investigations.
  • Manage the entire life cycle of vendor qualification, comprised of vendor pre-qualifications and vendor re-qualifications, including assembling and leading cross-functional vendor qualification teams, tracking requests, vendor services risk assessments, scheduling, maintaining an approved vendor services list, setting agendas, conducting vendor qualifications, leading evaluations, closing vendor qualification reports.

Skills and Requirements:

  • Bachelor's degree of higher with 8+ years of relevant experience in the pharmaceutical or bio-pharmaceutical industry.
  • Must have QA auditing experience within clinical trials. Must have experience with CAPAs and investigations.
  • Demonstrates a thorough knowledge of Good Clinical Practice "GCP", Good Pharmacovigilance Practices "GVP", Good Laboratory Practice "GLP", and Good Documentation Practice "GDP".

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.

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

Proclinical Staffing is an equal opportunity employer.

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