NEW: Quality Administrator – Veeva Vault QMS

G&L Scientific; San Diego (CA); In loco; USD 65.000 - 95.000; Tempo pieno

Descrizione del lavoro

G&L Scientific is seeking a Quality Administrator to support Veeva Vault QMS administration, focusing on audit and deviation management in a GMP/GxP environment in San Diego, CA. Responsibilities include maintaining quality records, tracking CAPAs and action items, coordinating with cross-functional stakeholders, and ensuring timely documentation and compliance with procedures and regulatory requirements.

Experience with electronic QMS systems, especially Veeva Vault QMS, and strong

Competenze

• 3–5 years of experience in Quality Assurance in a GxP environment.
• Hands-on experience with Veeva Vault QMS.
• Knowledge of audit management, deviation management, investigations, CAPAs and change control processes.
• Familiarity with GCP, GMP, or other applicable GxP requirements.
• Strong organizational skills and attention to detail.

Mansioni

• Administer audit records and documentation within Veeva Vault QMS.
• Coordinate audit scheduling, notifications, documentation requests, and follow-up activities.
• Track audit observations, findings, CAPAs, and due dates.
• Monitor audit action items and follow up with stakeholders.
• Maintain accurate audit records and supporting documentation.
• Generate audit status reports and metrics for QA leadership.
• Create, maintain, and track deviation records within Veeva Vault QMS.
• Coordinate deviation investigations, root cause analysis, and CAPA assignments.
• Monitor deviation timelines, approvals, and outstanding actions.
• Assist with record closure and verification of documentation.
• Support quality system reporting and inspection readiness.

Conoscenze

Audit management

Deviation management

CAPA management

Change control

GxP knowledge

Cross-functional coordination

Attention to detail

Formazione

Bachelor’s degree in life sciences

Strumenti

Veeva Vault QMS

Descrizione del lavoro

NEW: Quality Administrator - Veeva Vault QMS

Contract: 12 months, with potential for extension

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.

The Role

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.
• 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 elevate 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.

Requirements

• 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.
• Duration: 12 months, with potential for extension based on business needs.
• Reporting To: Quality Assurance Manager or designated Quality Systems Lead.

G&L Scientific is committed to equal opportunities and creating an inclusive environment where everyone is treated fairly, with dignity and respect.

We welcome applications from all suitably qualified candidates, regardless of age, disability, gender identity, marital status, pregnancy or maternity, race, religion or belief, sex, sexual orientation, or any other characteristic protected by applicable law.

We are committed to fair and inclusive recruitment practices and encourage applications from people of all backgrounds.