RemoteLeaf Logo
Log in Sign up

Senior Quality Assurance Auditor

2 hours, 37 minutes ago
Anywhere
Full-time
Lead
QA Engineer
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.
  • Plan, lead, and execute complex internal and external audits across the organization.
  • Prepare detailed audit reports and facilitate responses to audit observations.
  • Support the vendor management program by performing initial vendor audits.
  • Manage the audit process through the quality management system.
  • Lead or support continuous improvement initiatives for the Quality Management System, audit processes, and compliance to global standards.
  • Provide guidance and training on GxP requirements to functional area personnel.
  • Support inspections and help develop responses to agency observations.
  • Provide audit metrics to executive management.
  • Apply working knowledge of FDA, EU, GxP, CAP, and CLIA requirements.

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.
  • ASQ Certified Quality Auditor (CQA) or Lead Auditor certification strongly preferred.
  • Excellent written and verbal communication skills.
  • Strong interpersonal skills with the ability to influence and build credibility at all levels.
  • Attention to detail and ability to manage multiple processes and documentation requirements.
  • Analytical and problem-solving skills to evaluate complex compliance issues independently.
  • Advanced knowledge of Microsoft Office, including Word, Excel, and PowerPoint.
  • Experience with Veeva Quality Vault required.
  • Ability to work both independently and as part of a team.
  • Outstanding organizational skills with the ability to prioritize effectively.
  • Strong critical thinking and independent decision-making skills in a fast-paced environment.
  • Continuous improvement mindset and willingness to adapt to changing business and site needs.
  • Positive, approachable, and professional attitude.

Benefits

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

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

JetBrains

QA Engineer (Version Control Experience)

JetBrains 1K-5K Internet Software & Services

JetBrains is hiring an experienced QA Engineer for the Version Control Experience team to test and support VCS tools integration across its IDEs.

Czech Republic Poland Serbia Spain Cyprus Armenia Full-time Mid Level QA Engineer
Git IntelliJ IDEA SVN
37 minutes ago
ALTEN Technology

Material & Process Engineer II

ALTEN Technology 251-1K Construction & Engineering

ALTEN Technology USA is hiring a Material & Process Engineer for a 4-5 month project supporting manufacturing, materials testing, and specification development across aerospace and advanced engineering programs.

United States Full-time Junior QA Engineer
$80k-$90k
1 hour, 7 minutes ago
JetBrains

Senior QA engineer (BAD)

JetBrains 1K-5K Internet Software & Services

JetBrains is hiring a Senior QA Engineer to support its Business Applications Development team in testing and improving internal and external web applications that automate sales flow and license management.

Germany Serbia Cyprus Armenia Full-time Senior QA Engineer
IntelliJ IDEA Java Kotlin Postman SQL VS Code
1 hour, 22 minutes ago
Higher Logic

Sr. QA Analyst I

Higher Logic 251-1K Internet Software & Services

Higher Logic is hiring a Senior QA Analyst to support engineering projects by directing testing efforts, validating features, and improving product quality across its engagement platform.

United States Full-time Senior QA Engineer
Agile C# Java Scrum SQL
1 hour, 37 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers