Senior Quality Assurance Auditor

20 hours ago


Scranton, United States Planet Pharma Full time

Senior QA Auditor

Location: Onsite in Scranton, PA

Compensation: Market Rate

Experience Required: 2-3 years


Overview

We are seeking a Senior QA Auditor to join our team. This role involves a quick interview process and requires on-site presence.


Key Responsibilities

  • Conduct thorough and independent audits of study-related activities and documentation to ensure compliance with protocols, SOPs, GLP (21 CFR Part 58 and Part 11), and relevant regulatory requirements.
  • Report findings to the Study Director and Testing Facility Management.
  • Foster effective working relationships across the organization and mentor junior staff.


Primary Duties

  • Audit various phases of nonclinical and laboratory studies and issue QA statements to ensure regulatory compliance.
  • Perform in-life audits, process audits, vendor qualifications, and equipment/software validation audits.
  • Lead facility audits to verify compliance with regulations.
  • Maintain accurate computerized audit records and documentation.
  • Provide risk-based compliance insights and guidance.
  • Write and communicate inspection reports clearly to internal clients.
  • Ensure SOPs relevant to study conduct are current and followed.
  • Identify opportunities for process improvements based on audit findings and guide related activities.
  • Notify management of observed trends in quality and compliance.


Qualifications

  • Bachelor’s degree in a scientific discipline or equivalent experience.
  • 2-3 years of relevant technical experience, including at least 2 years in a GLP-regulated environment.
  • Professional certifications (e.g., RQAP-GLP or ASQ-CQA) are preferred.
  • Proficient in Microsoft Office Suite.
  • Commitment to ongoing training in audits, regulatory affairs, and GLP standards.



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