Job Description

Market rate - $40 - $55 (may be able to go higher for the right candidate)

6 month extendable CONTRACT

Hybrid - Redwood City CA - must be local

The Opportunity:

• Perform duties related to and maintain the GxP document control system consisting of product related documentation, quality manual, external documentation, department procedures and work instructions.
• Initiate and/or coordinate all incoming, in-process and completed document change control, associated supporting documentation and following up to ensure the changes are completed and documentation is properly closed out and released.
• Perform duties relate to and maintain GxP training program including the training assignments, archival of completed records, oversight of training compliance, and periodic auditing of training records.
• Train new users in using the document control and training systems, as needed.
• Provide guidance on document control practices and procedures to all functional departments.
• Support the maintenance and improvement of quality systems processes, as needed.
• Enforce compliance with processes/procedures, policies and GxP standards.
• Run reports for all aspects of the document control & training processes including training reports and generating metrics for QA and sub-functional teams, as needed.
• Works with internal stakeholders with assistance from QA leadership to ensure follow-up and closure of quality issues.
• Other tasks assigned by the management.

Required Skills, Experience and Education:

• 5+ years of relevant experience in bio-pharmaceutical environment Quality Systems
• Experience with Veeva QualiySuite Platforms (Veeva QualityDocs, VaultTraining, Veeva QMS)
• Bachelor of Science in Life Sciences, Engineering, or related discipline

Preferred Skills:

• Ability to work in a team environment, manage multi-tasking, and discipline in completing tasks on schedule.
• Excellent written and verbal communication skills.
• Proficient in Microsoft Office skills (WORD, Excel, PowerPoint).

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