Senior Quality Assurance Auditor

6 days ago


Scranton, Pennsylvania, United States Planet Pharma Full time
About the Role

The Senior QA Auditor is a critical member of our team at Planet Pharma, responsible for ensuring the highest standards of quality and compliance in our operations. This role involves conducting systematic and independent examinations of study-related activities and documents to verify adherence to protocols, SOPs, GLP, and regulatory requirements.

Key Responsibilities
  • Audit phases of nonclinical and laboratory studies, reports, and perform related duties to ensure regulatory compliance.
  • Audit all disciplines, including Method Validations, Non-Clinical GLP Studies, and vendor qualifications.
  • Perform in-life audits, process audits, equipment and software validation audits, and facility audits to ensure compliance with regulations.
  • Act as lead auditor on studies and projects, maintaining computerized files to support audit activities.
  • Support project planning and implementation, providing risk-based compliance opinions and guidance.
  • Write and issue inspection reports, working with internal clients to ensure clear communication and understanding of inspection findings.
  • Ensure SOPs are current and practiced through phase and data inspections.
  • Identify and communicate opportunities for process improvements based on audit and inspection observations.
  • Maintain necessary documentation of QA records and study files.
  • Notify management of observed quality and compliance trends in the areas inspected.
Requirements
  • Bachelor degree or higher in a scientific discipline, or equivalent combination of education and experience.
  • Two to three years related technical experience and/or training, with a minimum of two years auditing in a GLP-regulated environment.
  • Professional certification such as RQAP-GLP or ASQ-CQA is recommended.
  • Microsoft Office Suite proficiency.
What We Offer

At Planet Pharma, we offer a dynamic and supportive work environment, opportunities for professional growth and development, and a competitive compensation package.



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