Celcuity

Senior Quality Assurance Auditor

QA EngineerQA EngineerFull TimeRemoteSeniorTeam 51-200Company Site LinkedIn

Location

United States

Posted

2 days ago

Salary

$135K - $165K / year

Seniority

Senior

Bachelor Degree10 yrs expEnglishVault

Job Description

• 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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