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Senior Quality Assurance Auditor

2 months, 1 week ago
Anywhere
Full-time
Lead
Manual QA Tester
Quality Assurance and Testing
Apply Now
Celcuity

Celcuity

Celcuity is a clinical stage biotechnology company that unravels complexity and harnesses insights to develop targeted therapies for cancer patients. Their platform provides unparalleled insights into oncogenic pathways, with their lead candidate being...

Biotechnology
11-50
Founded 2012
$214M raised
View All Jobs 8

Description

  • Conduct vendor, investigator site, and internal audits in accordance with applicable GxP requirements.
  • Independently plan, lead, and execute complex internal and external audits across the organization.
  • Prepare detailed audit reports and manage responses to audit observations.
  • Support the vendor management program by performing initial vendor audits.
  • Manage audits and related activities through the quality management system.
  • Lead or participate in initiatives to improve the Quality Management System, audit processes, and compliance with global standards.
  • Provide guidance and training on GxP requirements to functional area personnel.
  • Support regulatory inspections and help develop responses to agency observations.
  • Provide audit metrics and reporting to Executive Management.
  • Perform other duties as assigned.

Requirements

  • Bachelor’s degree in health or life sciences, or equivalent relevant experience.
  • 10+ years of experience in auditing and quality management systems in the pharmaceutical, biotechnology, or medical device industry.
  • Experience working in a GxP-regulated environment.
  • Professional certifications such as ASQ Certified Quality Auditor (CQA) or Lead Auditor certification are highly preferred.
  • Working knowledge of FDA and EU regulatory requirements, and standards such as GxP, CAP, and CLIA.
  • Excellent written and verbal communication skills with the ability to influence and build credibility at all levels.
  • Strong interpersonal, analytical, and problem-solving skills with the ability to independently evaluate complex compliance issues.
  • Advanced knowledge of MS Office, including Word, Excel, and PowerPoint.
  • Experience with Veeva Quality Vault software required.
  • Strong organizational skills, attention to detail, and ability to manage multiple processes and documentation requirements.

Benefits

  • Base salary range of $135,000–$165,000 DOE.
  • Eligibility for an annual performance incentive bonus.
  • New hire equity package.
  • Medical, dental, and vision insurance.
  • 401(k) match.
  • Paid time off (PTO).
  • Paid holidays.

Interested in this position?

Apply directly on the company website

Apply Now

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