Senior Quality Assurance Auditor

QA EngineerQA EngineerOtherRemoteSeniorTeam 51-200H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

80 days ago

Salary

$135K - $165K / year

Seniority

Senior

Bachelor Degree10 yrs expEnglishHashiCorp Vault

Job Description

Senior Quality Assurance Auditor

Celcuity

• Conduct vendor, investigator site, and internal audits according to applicable GxP requirements. • Prepare detailed, high-quality audit reports and facilitate responses to audit observations. • Support the vendor management program by performing initial audits of vendors. • Manage the audit process through the quality management system. • Lead or participate in strategic initiatives to continuously improve the Quality Management System (QMS), audit processes, and overall compliance to global standards. • Provide guidance and training on GxP requirements to functional area personnel. • Provide guidance and support during inspections and assist in developing responses to agency observations. • Provide audit metrics to Executive Management.

Job Requirements

  • Bachelor's degree in health or life sciences; or relevant experience.
  • 10 plus (10+) years of experience in auditing and quality management systems in pharmaceutical, biotechnology, or medical device industry in a GxP regulated environment.
  • Relevant professional certifications such as ASQ Certified Quality Auditor (CQA) or a Lead Auditor certification are highly preferred.
  • Strong knowledge of regulatory requirements (FDA, EU) and related standards (GxP, CAP, CLIA).
  • Experience with Veeva Quality Vault software required.

Benefits

  • Medical insurance
  • Dental insurance
  • Vision insurance
  • 401(k) match
  • PTO
  • Paid holidays
  • Annual performance incentive bonus
  • New hire equity package

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