GxP Document Control Specialist (EDMS & GMP)

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

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.