Documentation Specialist II

Position Title: Documentation Specialist
Work Location: Remote (Local to Irvine, CA)
Assignment Duration: 2 years (possible extension- performance based)
Work Schedule: Potential for schedule flexibility to cover EU sites to West Coast US time zones preferred.
Work Arrangement: Fully Remote with occasional onsite flexibility

Position Summary: Self-starter with attention to detail individual to handle product documentation requests from receipt to approved in document management system. Good communication skills in ensuring timelines are met.

Background & Context: Responsible for supporting documentation lifecycle and compliance within our organization.

Key Responsibilities:

• Responsible for processing GxP documents in a document management system.

• May be responsible for maintaining department's record archival and retention schedule in compliance with Corporate Record policies and procedures including GxP (GLP/GMP) requirements

• May be responsible for supporting purchasing equipment, tracking and follow-up, working in a matrixed environment, managing shifting priorities.

Qualification & Experience:

• Minimally high school equivalent and/or relevant experience

• Self-starter with superior organizational and communication skills

• Ability to effectively execute tasks with little oversight

• Experience with Microsoft Office, DocXTool, OneVault, PowerApp preferred.

• Demonstrated outcome implementing process workflow improvements including potential applications for AI/ML tools preferred.

• Potential for schedule flexibility to cover EU sites to West Coast US time zones preferred.