Document Control Specialist

The Quality Assurance team is is committed to maintaining rigor, compliance, and excellence across all GxP operations. As a Document Control Specialist, you will partner closely with cross-functional teams in Manufacturing, Quality, and Clinical operations to manage our Electronic Document Management System (EDMS). Together, our team ensures continuous inspection readiness and operational excellence, directly supporting our mission to deliver safe, transformational therapies to patients.

The Opportunity

In this role, you will oversee the lifecycle of controlled GxP documentation and records management to ensure full regulatory compliance and seamless operational execution.

This is an on-site position in San Diego.

• Coordinate and manage document change control workflows for SOPs, Work Instructions, and controlled forms across GxP operations.
• Format, review, and release controlled documents in accordance with established internal procedures and project timelines.
• Issue, track, and reconcile critical GMP documentation, including batch records, laboratory notebooks, and logbooks for production and testing.
• Maintain document master copies, archive original production records, and execute record retention processes through scanning and filing.
• Support the implementation, validation, and ongoing administration of the EDMS, including authoring user requirements and updating workflows.
• Compile and report Quality system metrics to track operational performance and compliance trends.
• Support internal audits and regulatory agency inspections, ensuring documentation is readily retrievable and audit-ready.

Who You Are

• You hold a Bachelor’s degree in a science-related field preferred, or an equivalent combination of education and relevant experience.
• You bring 1-2 years of experience within a pharmaceutical, biotechnology, or GxP/GMP-regulated environment.
• Foundational understanding of document control principles, change control processes, and records management practices is required

Behaviors, competencies, and qualities of the ideal applicant.

• Strong proficiency with personal computers and office productivity suites, specifically advanced document formatting in Microsoft Word and data tracking in Microsoft Excel.
• You are attentive to detail with proven organizational skills to manage multiple priorities efficiently in a fast-paced setting.
• You can work independently with minimal oversight and maintain strong interpersonal, communication, and conflict-resolution skills when partnering with cross-functional stakeholders.

Relocation benefits are not approved for this posting.

The expected salary range for this position based on the primary location of California is $54,400 - $85,470. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed in this link. Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.