About this position
Position Summary
The Quality Administrator will support the administration and ongoing management of quality processes within Veeva Vault QMS, with a primary focus on audit and deviation management. This role is responsible for maintaining accurate quality records, monitoring action items and timelines, coordinating with stakeholders, and ensuring quality events are documented and managed in accordance with applicable procedures and regulatory requirements.
The ideal candidate has hands-on experience with electronic QMS platforms, specifically Veeva Vault QMS, and a working knowledge of GxP quality processes within the pharmaceutical or biotechnology industry.
Key Responsibilities
Audit Management
- Administer audit records and associated documentation within Veeva Vault QMS.
- Coordinate audit scheduling, notifications, documentation requests, and follow-up activities.
- Track audit observations, findings, corrective and preventive actions (CAPAs), and associated due dates.
- Monitor audit action items and follow up with responsible stakeholders to support timely completion.
- Maintain accurate and complete audit records and supporting documentation.
- Generate audit status reports and metrics for Quality Assurance leadership.
Deviation Management
- Create, maintain, and track deviation records within Veeva Vault QMS.
- Coordinate deviation documentation, investigation activities, root cause analysis, and CAPA assignments.
- Monitor deviation timelines, required approvals, and outstanding actions.
- Follow up with process owners to ensure records are complete and progress is documented.
- Support deviation trending and reporting to identify recurring issues and overdue activities.
- Assist with record closure activities by verifying required documentation and approvals are present.
Veeva Vault QMS Administration
- Maintain data integrity, record accuracy, and completeness within the system.
- Support workflow execution, record routing, notifications, and approval processes.
- Assist users with routine system navigation and troubleshooting.
- Identify recurring system or process issues and escalate them to the appropriate stakeholders.
- Support quality system reporting, metrics, and inspection-readiness activities.
- Contribute to process improvements and updates to applicable procedures and work instructions, as needed.
Qualifications and Experience
- Bachelor’s degree in life sciences, healthcare, quality management, or a related field preferred.
- Approximately 3–5 years of experience in Quality Assurance, quality systems administration, or a related GxP environment.
- Hands-on experience with Veeva Vault QMS
- Working knowledge of audit management, deviation management, investigations, CAPAs, and change control processes.
- Familiarity with GCP, GMP, or other applicable GxP requirements in the pharmaceutical or biotechnology industry.
- Strong organizational skills and attention to detail, with the ability to manage multiple records and competing deadlines.
- Proficiency in Microsoft Office, including Excel and Word.
- Effective written and verbal communication skills and the ability to coordinate across cross-functional teams.
Contract Details
- Duration: 12 months, with potential for extension based on business needs.
- Work Arrangement: On-site in San Diego, CA office.
- Reporting To: Quality Assurance Manager or designated Quality Systems Lead.
Location and commute
San Diego Country Estates, CA 92189.
Plan your route with Google Maps. Travel times and transportation options vary; confirm the work location with the employer before commuting.
How to apply
Review the vacancy and complete the application on the employer or recruitment partner’s website. Requisition ID: WJ-3199507836.