Job Description

Exciting new contract with our key Biotech client in the Bay Area for an initial 6 month contract, with extension likely. Ideal candidate will be experienced with Veeva Systems and have previous experience in training the GxP Quality Systems...

The Opportunity:

• Manage and maintain the GxP document control system, which includes product-related documentation, quality manuals, external documents, departmental procedures, and work instructions.
• Coordinate all aspects of incoming, in-process, and completed document change controls, ensuring supporting documentation is provided, changes are completed, and documentation is properly closed out and released.
• Oversee and maintain the GxP training program, including assigning training, archiving completed records, monitoring compliance, and conducting periodic audits of training records.
• Train new users on the document control and training systems, as needed.
• Provide guidance on document control practices and procedures to various departments.
• Support the maintenance and enhancement of quality systems processes, as required.
• Ensure adherence to company processes, procedures, policies, and GxP standards.
• Generate reports related to document control and training processes, including training compliance and metrics for QA and other teams.
• Collaborate with internal stakeholders and assist QA leadership in resolving and closing quality issues.
• Perform additional tasks as assigned by management.

Required Skills, Experience, and Education:

• 5+ years of relevant experience in the pharmaceutical or biotech industry with a focus on Quality Systems.
• Experience with document control and training systems (e.g., Veeva QualityDocs, VaultTraining, Veeva QMS).
• Bachelor’s degree in Life Sciences, Engineering, or a related field.

Preferred Skills:

• Ability to work collaboratively within a team, manage multiple tasks, and meet deadlines.
• Strong written and verbal communication skills.
• Proficient in Microsoft Office (Word, Excel, PowerPoint)

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