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Clinical Quality Assurance Auditor

Clinical Quality Assurance Auditor

Job Description

DESCRIPTION OF JOB DUTIES
 

  • Coordinate and conduct internal system audits and external investigative site/vendor audits;
  • Create, maintain, and revise departmental standard operating procedures, forms, and templates;
  • Host audits by sponsors and regulatory inspectors;
  • Coordinate, conduct, and track company-wide regulatory training (ICH/GCP and medical device);
  • Develop training materials and applicable tests and guides;
  • Work with outside clients/sponsors; and
  • Other items as deemed necessary.

Job Requirements

QUALIFICATIONS/REQUIREMENTS
 

  • Bachelor’s degree in life sciences;
  • 2-5 years of experience in a QA department in a related industry;
  • Experience conducting audits of vendors and investigative sites
  • Experience hosting regulatory authorities and interacting with sponsor/client representatives;
  • Independent thinking and planning ability;
  • Knowledge and application of GCP is required;
  • Medical Device and or Phase 1 experience is a plus;
  • Ability to travel up to 50% of time;
  • Excellent written and verbal communication skills;
  • Exceptional teamwork skills; and
  • Ability to work independently.

 

Travel: Average of 50%
 

WHAT TO EXPECT NEXT
 

We look forward to receiving your application. A member of our recruitment team will review your qualifications. If interested, you will be contacted for an interview.
 

EO/AA Employer M/F/Disability/Vets

Job Snapshot

Employment Type Full-Time
Job Type QA - Quality Control, Pharmaceutical, Biotech
Education Not Specified
Experience Not Specified
Manages Others Not Specified
Industry Pharmaceutical, Biotechnology, Healthcare - Health Services
Required Travel Not Specified
Job ID US-QACL
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Clinical Quality Assurance Auditor


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