QA Auditor I

2 months ago

Malvern, United States Resolian Full time

Responsibilities

  • Audit documents against regulatory requirements; GLP, GCP, EPA, OECD, 21CFR Part 11
  • Verify lab tasks are performed in accordance to Good Documentation Practices (GDP)
  • Audit laboratory documents and notebooks (e.g. plans, experiment/sample runs, chromatograms, instrument logs, etc.) for compliance to SOPs and applicable regulations
  • Audit data files and reports
  • Audit computer systems, facility operations, and other non-study regulated activities
  • Assist with maintaining Master Schedule
  • Identify non-compliance, deviations, and assist with resolution
  • Escalate data integrity and non-compliance issues to Management
  • Follow applicable SOPs and procedural documents
  • Assist with template and SOP review
  • Participate in client audits as needed
  • Enforce lab safety SOPs and requirements
  • Review system audit trails
  • Other tasks as assigned

Education, Experience & Skills Required

  • BA/BS or higher; all experiences will be evaluated
  • Knowledge of regulatory requirements; GLP, GCP, EPA, OECD, 21CRF Part 11, GDP, GMP
  • Familiar with pharmaceutical or biotechnology industry
  • Able to review detailed data and documents; communicate effectively
  • Able to work effectively and contribute within a team
  • Able to work with computer systems


About Us

Are you interested in working in science for a leading global Contract Research Organization that is expanding rapidly and delivering best in class service to its clients? If you are ambitious and hard working then keep reading, as we are looking for talented individuals like you.

We are globally recognised for our leadership in science and, as a result, you will have the opportunity to work with some of our industries smartest and most inquisitive people, in a flexible and supportive environment. It is the ideal place to expand your knowledge, take on new responsibilities and make ambitious strides in your career.

If you want to join us to help us deliver our mission of using our scientific capabilities to improve the quality of life of people, then we would love to hear from you.

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