Organizes and hosts Vendor audits to support global operations (including preparation of audit plans, audit checklists, audit reports and certificates)
Manages complex audit activities in accordance with the Premier Research Vendor audit schedule and ensures the approved vendor list remains up to date and that only approved vendors are listed as available for use at a study level.
Acts as Point of Contact (POC) for vendor audit activities.
Ensures compliance with established internal control procedures by examining records, reports, operating practices, and documentation.
Communicates audit findings by preparing a final report; discussing findings with auditees.
What we are searching for:
Bachelor's degree, or international equivalent from an accredited institution, in Health or Life Sciences, or equivalent experience
5-8 years specialized GxP experience in auditing (i.e., vendor audits), or 8+ years relevant experience with 5+ years' experience conducting Vendor audits
Ability to interpret controlled documentation (i.e., protocols, validation documents, manufacturing records and data)
Demonstrated ability to independently review the majority of the following: databases, trial master files, investigator sites, statistical/clinical study reports, vendors, manufacturers,
master batch records, device history files, laboratories, system validation documentation
Demonstrated knowledge of ICH Guidelines, FDA Code of Federal Regulations and other applicable regulatory authority laws and regulations
Preferred Location: Central / Midwest
Please note this is a part-time 6 month 1099 contractor opportunity
Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The actual salary will be influenced based on a variety of factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status
Benefits
Health insurance
Additional Information
Premier Research is looking for a Senior Auditor, Vendor Audit to join our Functional Services Provider (FSP) team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
Premierresearch · US