QA Auditor - Monroe, North Carolina United States - 43921



JOB DESCRIPTION

Job #: 43921
Title: QA Auditor
Job Location: Monroe, North Carolina - United States
Employment Type:
Salary: $90,000.00 - $100,000.00 - US Dollars - Yearly
Employer Will Recruit From: Nationwide
Relocation Paid?: NO

WHY IS THIS A GREAT OPPORTUNITY?


   

JOB DESCRIPTION

Job Responsibilities:

  • CMO/Vendor Audit activities which includes:
    • Perform vendor audits of existing and new CMO/CPO/CTL/Vendors
    • Preparing/Review/Approval of audit reports and carry out follow-ups regarding audit report response from CMO/Vendors and ensure adequate implementation of proposed CAPAs by CMO/Vendors. 
    • Ensure that CMO/Vendor audits are carried out per audit schedule 
    • Review Quality Agreements with CMO and Vendors
    • Reviewing CMO QMS documents like Deviations, investigations, protocols, change controls, process validation, etc. if required
    • Collection of Vendor-specific documents like GMP and Debarment Certificate, latest EIR, Regulatory Accreditation, SOP list, Instrument List, Site Master File / Quality Manual etc. for reference. 
    • Maintain vendor audit response tracking spreadsheet
    • Support regulatory inspections (FDA, VAWD, NABP, etc.)
    • Handle/carry out other QA related activities/projects as assigned by supervisor

QUALIFICATIONS

  • Experience conducting vendor audits of existing and new CMO/CPO/CTL/Vendors
  • Ensure that audits are carried out per audit schedule
  • Able to multi-task and prioritize workload

Education:
University - Bachelor's Degree/3-4 Year Degree

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