Veeva User Remediation and Document Control/Training Specialist

The Veeva User Remediation and Document Control/Training Specialist is responsible for performing user testing in Veeva QualityDocs and Vault Training in support of remediation activities and paper-based Document Control and Training activities.

Location: South San Francisco, CA

Job Responsibilities:

• Perform user testing in sandbox environments for Veeva QualityDocs and Vault Training
• Perform Document Control activities including the routing of documents via wet-ink or DocuSign Part 11, update sharepoint of controlled documents, and notify updates of controlled documents.
• Perform Training activities including the routing of the documentation of training via wet-ink or DocuSign Part 11, schedule training for new hires, and evaluate training quizzes and worksheets.
• Perform verification of scanned documents for training to ensure compliance to 21 CFR Part 11.

Qualifications:

• Bachelor’s degree in Chemistry or Biological Science
• 10 years’ experience in biopharmaceutical industry
• 5 years’ experience in Veeva QualityDocs and Vault Training including performing user testing in sandbox environments for workflows, curricula, quizzes, and training requirements.
• 2 years’ experience in DocuSign Part 11 as an administrator including routing bulk send documents.
• Familiar with US FDA, EMA, and ICH regulations and guidelines
• Knowledge of QA systems and GMP compliance requirements
• Proven track record working in a multi-functional team environment
• Prior QMS implementation experience
• Strong oral and written communication skills needed
• Excellent interpersonal skills