Document Control Specialist

Genentech; San Diego (CA); On-site; USD 78,000 - 144,000; Full time

Job summary

Genentech is seeking a Document Control Specialist to join our Quality Assurance team in California. You will manage the EDMS and related change control processes across GxP operations to ensure total document compliance and alignment with GMP activities.

You will author and update controlled documents, issue master copies of critical GMP records, and support inspections and internal audits. Strong communication and independent work capability are essential in a fast-paced environment.

Qualifications

• Bachelor’s degree in a science-related field preferred.
• 2+ years of pharmaceutical GMP/GxP experience.
• Experience with EDMS implementation or validation procedures.
• Proficient in Word, Excel, and Adobe Acrobat.
• Detail-oriented with strong organizational skills.
• Ability to work cross-functionally and independently.

Responsibilities

• Manage the end-to-end document change control process for GxP operations across manufacturing, clinical, and product quality documentation.
• Author, format, and update controlled documents like SOPs, Work Instructions, and forms to internal standards.
• Issue and maintain master copies of GMP records including batch records, lab notebooks, and logbooks.
• Administer records management: scanning, archiving, filing, and master record retention.
• Collaborate with authors and reviewers across departments to process updates within timelines and regulatory guidelines.
• Support regulatory inspections and internal quality audits, generating key Quality system metrics on request.
• Assist with EDMS updates, GMP trainings, and write user requirements or changes per validation procedures.

Skills

Detail-oriented

Organizational skills

Cross-functional collaboration

Excellent communication

Education

Bachelor’s degree in science-related field

2+ years GMP/GxP pharma experience

Tools

EDMS

Microsoft Word

Microsoft Excel

Adobe Acrobat

Job description

The Position

This role is a valuable part of our Quality Assurance team, which is committed to maintaining rigor, compliance, and excellence across all GxP operations. As a member of this team, you will collaborate closely with cross-functional stakeholders—including Document Authors, Quality reviewers, and Operations personnel—to implement and support our Electronic Document Management System (EDMS). Together, the team plays a critical role in safeguarding product quality and ensuring regulatory readiness so we can reliably deliver transformational medicines to patients.

The Opportunity

As a Document Control Specialist, you will manage, maintain, and support the Electronic Document Management System (EDMS) and associated change control processes across GxP operations. In this role, you will ensure total document compliance, seamless record issuance, and cross-functional alignment in support of GMP manufacturing and quality activities.

• Manage the end-to-end document change control process for GxP operations, including manufacturing, clinical, and product quality documentation.
• Author, format, and perform periodic updates for controlled documents such as SOPs, Work Instructions, and Controlled Forms to ensure adherence to internal standards.
• Issue and maintain master copies of critical GMP execution records, including batch records, laboratory notebooks, and logbooks.
• Administer records management procedures, encompassing scanning, archiving, filing, and master record retention.
• Partner with document authors and reviewers across departments to process updates within strict project timelines and regulatory guidelines.
• Support regulatory inspections and internal quality audits, including generating key Quality system metrics upon request.
• Assist with EDMS updates, conduct GMP trainings, and author user requirements or implementation changes in alignment with validation procedures.

Who You Are

• Education: Bachelor’s degree in a science-related field preferred.
• Experience: 2+ years of pharmaceutical experience operating within a GMP and/or GxP environment.
• Technical Knowledge: Basic understanding of document control concepts and experience with EDMS implementation or validation procedures.
• Software Proficiency: Strong personal computer skills, with proficiency in Microsoft Word, Microsoft Excel, and Adobe Acrobat.
• Core Competencies: Highly detail-oriented with excellent organizational skills and the ability to execute multiple priorities in a fast-paced environment.
• Soft Skills: Strong written and verbal communication skills, with solid interpersonal capabilities to manage cross-functional alignment and resolve operational conflicts.
• Autonomy: Self-motivated and capable of working independently with minimal supervision.

The expected salary range for this position based on the primary location of California is $77,500 - $143,900. 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.

Relocation benefits are not approved for this posting.

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.