Documentation Specialist

Documentation Specialist III

Pay Range: $25/hr to $28/hr

Location: Irvine, CA 92612

Work Type: Hybrid

Contract Duration: 2 years, possible extension

Job Summary:

Responsible for managing product documentation requests from receipt through approval within a document management system. Supports accurate and timely processing of GxP documentation while maintaining strong attention to detail and compliance requirements. Works independently with minimal oversight while coordinating with cross functional teams and stakeholders. Supports documentation workflows, archival activities, process improvements, and shifting business priorities. May provide schedule flexibility to support teams across European and United States time zones.

Key Responsibilities:

• Process GxP documents through established document management systems and ensure documentation requests are completed within required timelines.
• Maintain accurate department records and support archival and retention activities in accordance with corporate record policies and applicable GxP requirements.
• Coordinate with cross functional teams to manage documentation requests, follow ups, purchasing activities, equipment tracking, and related administrative requirements.
• Monitor documentation workflows and communicate effectively with stakeholders to ensure timely completion and resolution of outstanding items.
• Support process workflow improvements and identify opportunities to leverage enterprise tools and emerging AI and Machine Learning applications.
• Manage shifting priorities independently while maintaining accuracy, organization, and compliance.

Required Qualifications:

• High school diploma or equivalent education and relevant professional experience.
• Strong organizational and communication skills.
• Ability to work independently with minimal oversight.
• Strong attention to detail and ability to manage multiple priorities.
• Experience working with controlled documentation or regulated processes.
• Ability to effectively coordinate with cross functional stakeholders.

Preferred Qualifications:

• Experience with MS Office and enterprise document management tools.
• Experience with DocXTool, OneVault, or PowerApp.
• Experience supporting GxP, GLP, or GMP documentation processes.
• Experience implementing workflow or process improvements.
• Exposure to AI and Machine Learning applications for business process improvement.
• Ability to support flexible schedules covering European and United States time zones.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)