EDMS & GxP Compliance 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

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.