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Clinical Quality Auditor
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Astrix Technology
South San Francisco, CA (In Person)
$140,400 Salary, Full-Time
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Job Description
- Clinical Quality Auditor
- CQC/Clinical Quality Assurance South San Francisco, California, US + Added - 19/03/2026 _Our client is a patient-driven cardiovascular biotechnology company dedicated to advancing heart disease treatment by developing therapies that address the root causes of disease rather than managing symptoms alone._
Title:
- GCP Auditor
Location:
- Hybrid (3 days onsite, South San Francisco, CA)
- Pay rate:
- $60-75hr+ Depends on experience
Schedule:
- Full-time, M-F 8am-5pm
- Contract-to-hire
- We are seeking a
- GxP Auditor
- to join a quality team in a contract-to-hire capacity. This role is ideal for a seasoned auditor with strong GMP experience who is looking to contribute to a growing organization while supporting and helping scale a global audit program.
- Role Overview
- The GxP Auditor will be responsible for executing and supporting audits across internal operations, vendors, and investigator sites, ensuring compliance with global regulatory standards. This individual will also play a key role in strengthening audit program infrastructure, supporting audit reporting, and managing CAPA lifecycle activities.
- Key Responsibilities
- + Plan and conduct
- GxP audits
- (primarily GMP), including vendor and clinical/investigator site audits + Perform
- audit report reviews
- and ensure alignment with regulatory and quality standards + Support the
- audit lifecycle
- , including CAPA review, approval, and closure + Contribute to the development and improvement of
- audit program infrastructure
- + Collaborate cross-functionally with Quality and Operations teams + Participate in scheduled audits across multiple regions (domestic and some international travel) + Support upcoming
- GCP audits
- and ongoing audit planning activities +
Travel:
- 20-50%
- Qualifications
- + •MUST be a Certified Auditor (required)•+ 5-10+ years of experience in •Quality, Compliance, or GxP auditing/inspections•+ Strong working knowledge of •FDA, EMA, ICH, and GMDP regulations•+ Hands-on experience conducting •GMP audits•(vendor and/or clinical site audits preferred) + Experience reviewing audit reports and managing •CAPAs•+ Bachelor's or advanced degree in •Life Sciences, Pharmacy, Chemistry, or related field•+ Experience in biotech/pharma environments •Preferred•+ Experience with •MHRA and Health Canada•regulations + Familiarity with •Veeva and/or Smartsheets•+ Strong communication, collaboration, and stakeholder management skills INDBH \#LI-MG1We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.