Documentation Specialist- GxP

Documentation Specialist- GxP

Location: North Chicago, IL (Hybrid, Tu-TR onsite, M&F remote)

Duration: 2-Year Contract (temp-to-perm opportunity)

RATE: $26/hr

Orion Group is seeking a highly organized and detail-oriented Documentation Specialist to support a leading global pharmaceutical organization. This role is ideal for a self-starter who thrives in a fast-paced, regulated environment and enjoys managing documentation processes from initiation through final approval.

The successful candidate will play a critical role in ensuring product documentation is processed accurately, efficiently, and in compliance with quality and regulatory requirements. This position offers the opportunity to contribute to process improvement initiatives, support cross-functional teams, and help drive operational excellence through innovative solutions.

Key Responsibilities

• Process and manage GxP-controlled documents within electronic document management systems from submission through approval.
• Ensure documentation is completed accurately and within established timelines while maintaining compliance with internal procedures and regulatory requirements.
• Support document lifecycle management, including revisions, approvals, archival, retention, and retrieval activities.
• Maintain departmental record archival and retention schedules in accordance with corporate records policies and GxP requirements (GLP/GMP).
• Collaborate with cross-functional stakeholders to coordinate documentation requests, resolve issues, and ensure timely completion of deliverables.
• Support departmental operational activities, including equipment purchasing, tracking, and follow-up as needed.
• Identify and implement opportunities for process improvements, workflow optimization, and increased operational efficiency.
• Explore and support potential applications of AI/ML tools and automation solutions to enhance documentation processes.
• Effectively manage multiple priorities and shifting deadlines within a matrixed organization.

• High School Diploma or equivalent combination of education and relevant experience.
• Strong organizational skills with exceptional attention to detail.
• Excellent verbal and written communication skills.
• Ability to work independently with minimal supervision and take ownership of assigned responsibilities.
• Demonstrated ability to manage multiple tasks and meet deadlines in a fast-paced environment.
• Proficiency with Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint.

• Experience working in a regulated environment, preferably within pharmaceutical, biotechnology, healthcare, or manufacturing industries.
• Experience with document management systems and electronic quality documentation processes.
• Familiarity with DocXTool, OneVault, PowerApp, or similar systems.
• Experience supporting GxP documentation requirements, including GLP and GMP environments.
• Demonstrated success implementing process improvements, workflow enhancements, or automation initiatives.
• Interest or experience in leveraging AI/ML tools to improve operational processes.
• Flexibility to occasionally support stakeholders across global time zones, including European and West Coast U.S. teams.

• Hybrid opportunity 3 days onsite/2 days remote.
• Long-term contract with potential for extension or conversion.
• Opportunity to support a global pharmaceutical leader.
• Exposure to quality systems, process improvement initiatives, and emerging technologies.
• Collaborative and highly visible role supporting critical business operations.

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.