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Quality Assurance Auditor

1 month ago

Overland Park, Kansas, United States Altasciences Full time
About the Role

The QA Auditor is responsible for conducting systematic and independent examinations of trial-related activities and documents to ensure compliance with regulatory requirements.

Key responsibilities include auditing phases of laboratory and clinical studies, reporting findings, and ensuring that SOPs are current and practiced.

The ideal candidate will have a strong understanding of GCP and GCLP regulations and be able to interpret them to facilitate auditing and process improvement recommendations.

What You'll Do Here
  • Audit phases of laboratory and clinical studies, reports, and perform related duties to ensure regulatory compliance.
  • Perform in-life audits, process audits, vendor qualifications, equipment and software validation audits.
  • Write and issue inspection reports, work with internal clients to ensure that inspection findings are clearly communicated and understood.
  • Ensure through phase and data inspections that the SOPs involved in the conduct of a study are current and practiced.
  • Identify and communicate opportunities for process improvement based on audit and inspection observations.
What You'll Need to Succeed
  • Bachelor degree or higher in Chemistry, Biochemistry, Biology, or equivalent field, or equivalent combination of education and experience in the pharmaceutical industry.

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.