QA Documentation Specialist II

Summary

This role provides critical support to the PQS (Pharmaceutical Quality System) integration at the Vacaville site during its transition from Roche to Lonza, ensuring full compliance with cGMP standards and global quality requirements. The position plays a key role in coordinating documentation, managing workflows, and maintaining inspection readiness throughout the integration process.

Key Responsibilities

• Support the implementation, execution, and maintenance of PQS integration and Quality Documents within Veeva at the Vacaville site.
• Collaborate with site SMEs to identify touchpoints, dependencies, and gating related to PQS integration CAPAs.
• Assist SMEs in developing project plans and timelines to ensure smooth coordination of change activities.
• Partner with the Quality Document Control team to manage document workflows, gating, and changes, ensuring minimal impact on site operations.
• Manage Quality Documents by initiating, formatting, editing, and maintaining control documents within Veeva Quality Docs.
• Track and log requests for source documents to ensure proper documentation flow and traceability.
• Ensure all activities comply with cGMP and global regulatory requirements.
• Maintain a constant state of inspection readiness to support site quality objectives.
• Assess the impact of discrepancies on the qualified state of equipment related to qualification-relevant topics.

Skills and Qualifications