Sr. Quality Auditor

Simtra BioPharma Solutions

Bloomington, United States
On-site
Cgmp regulations
Quality system conformance
Client and regulatory inspections
Simtra BioPharma Solutions is seeking a Senior Quality Auditor to join their Quality Assurance Team in Bloomington, Indiana. The ideal candidate will have extensive experience in the pharmaceutical industry, particularly in quality auditing, and will be responsible for ensuring compliance with cGMP regulations and leading audits

Job Summary

  • Conducts internal audits ensuring compliance with all applicable cGMP regulations, processes, systems and provisions of the Quality System.
  • Hosts and manages regulatory authority and client inspections, serving as a technical expert within the Quality Auditing department.
  • Evaluates corrective and preventive action responses to assessment findings for adequacy, including root cause and timeliness.

Matching Summary

Match Score: 85

Simtra BioPharma Solutions is seeking a Senior Quality Auditor to join their Quality Assurance Team in Bloomington, Indiana. The ideal candidate will have extensive experience in the pharmaceutical industry, particularly in quality auditing, and will be responsible for ensuring compliance with cGMP regulations and leading audits.

Skills & Requirements

Must-have

  • cGMP regulations
  • quality system conformance
  • client and regulatory inspections
  • corrective and preventive action evaluation
  • procedure gap assessments

Nice-to-have

  • growth mindset
  • teamwork and respect
  • high standard of excellence
  • impact on patient health
  • continuous improvement

Key Requirements

  • Bachelors degree in science or technical discipline
  • Minimum 5 years pharmaceutical industry experience
  • Minimum 3 years auditing experience
  • ASQ and/or RAB auditor accreditation desired
  • Expertise in GMP regulations

Work Rights

Not specified

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