Document Control Specialist

F. Hoffmann-La Roche AG; San Diego (CA); On-site; USD 78,000 - 144,000; Full time

Benefits offered by this job

Discretionary bonus (if applicable)

Benefits package

Job summary

Genentech, a Roche company, is seeking a Document Control Specialist to manage the EDMS and GMP change control across GxP operations. You will maintain controlled documents and ensure compliance while coordinating with multiple departments to meet regulatory timelines.

You will report to the quality/document control team, author updates, manage master records, and support inspections. A science degree and 2+ years of GMP/GxP experience are preferred.

Qualifications

• Bachelor's degree in a science-related field preferred.
• 2+ years of pharmaceutical GMP/GxP experience.
• Basic understanding of document control concepts and EDMS.

Responsibilities

• Manage end-to-end change control for GxP docs across departments.
• Author, format, and update SOPs, work instructions, and forms.
• Issue and maintain master records including batch records and notebooks.
• Administer records management: scanning, archiving, filing, retention.
• Collaborate with authors/reviewers to meet project timelines and regs.
• Support inspections and audits; generate quality metrics as requested.
• Assist with EDMS updates and train users per validation procedures.

Skills

Document control

EDMS

GxP experience

Microsoft Word

Microsoft Excel

Adobe Acrobat

Education

Bachelor's degree in science-related field

Tools

EDMS

Job description

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.

Salary

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, geographical location, and other job‑related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Benefits

This position also qualifies for the benefits detailed in this link.

Relocation

Relocation benefits are not approved for this posting.

Equal Opportunity and Accessibility

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.

Who We Are

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life‑threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. The next step is yours.