Documentation Specialist - GxP Document Mgmt

Documentation Specialist – GxP Document Management

Location: Irvine, CA – Fully Remote (Local Candidates Required)
Work Arrangement: Remote, with flexibility to visit the Irvine office occasionally as business needs arise.
Contract Duration: 2 years, contingent on performance and business needs.
Schedule: Flexibility to accommodate occasional collaboration across European and U.S. West Coast time zones preferred.

Up to $25/HR- Benefits offered at a cost 

Orion Group is seeking a highly organized, detail-oriented Documentation Specialist to support document management and operational processes for our global pharmaceutical client.
This opportunity is ideal for a self-motivated professional who enjoys working independently, managing multiple priorities, and ensuring documentation is processed accurately and efficiently in a regulated environment.
The successful candidate will manage product documentation requests from initial receipt through final approval within a document management system, collaborating with cross-functional teams to ensure accuracy, compliance, and timely completion.

Key Responsibilities

Document Management & Compliance

• Process GxP documentation within an electronic document management system, ensuring accuracy, completeness, and timely approval.
• Manage documentation requests from initial receipt through final approval, tracking progress and following up with stakeholders as needed.
• Maintain organized, accurate documentation in accordance with applicable procedures and regulatory requirements.
• Support departmental record archival and retention activities in compliance with corporate records policies and applicable GLP/GMP requirements, as assigned.

Operational & Cross-Functional Support

• Communicate effectively with internal stakeholders to clarify documentation needs, resolve issues, and ensure timelines are met.
• Independently manage competing priorities while maintaining a high level of accuracy and attention to detail.
• Support equipment purchasing, order tracking, and follow-up activities as needed.
• Collaborate across teams in a matrixed environment, adapting to changing priorities and business needs.

Process Improvement

• Identify opportunities to improve documentation workflows, efficiency, and consistency.
• Support the implementation of process improvements and streamlined document management practices.
• Contribute to workflow enhancement initiatives, including potential applications of AI/ML tools where appropriate.

Required Qualifications

• High school diploma or equivalent and/or relevant professional experience.
• Strong organizational skills and exceptional attention to detail.
• Excellent written and verbal communication skills.
• Demonstrated ability to work independently, take initiative, and execute tasks with minimal oversight.
• Ability to manage multiple documentation requests, shifting priorities, and deadlines effectively.
• Proficiency with Microsoft Office applications.

Preferred Qualifications

• Previous experience processing GxP documentation in a pharmaceutical, biotechnology, medical device, or other regulated environment.
• Familiarity with GLP/GMP requirements, document control, records management, or electronic document management systems.
• Experience with DocXTool, OneVault, and/or Power Apps.
• Demonstrated experience implementing workflow improvements or process efficiencies.
• Exposure to AI/ML tools or automation initiatives supporting operational improvements.
• Flexibility to occasionally accommodate meetings or business needs across European and U.S. West Coast time zones.

What We're Looking For

We're looking for someone who can take ownership of documentation requests, follow them through to completion, and communicate proactively to keep work moving.
The ideal candidate is organized, resourceful, comfortable working with limited supervision, and interested in identifying opportunities to improve existing processes.
Interested in learning more?
Apply today or connect with Danielle StGeorge at Orion Group to discuss this opportunity!


People are our business worldwide
 
Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.