Documentation Specialist III

About the role

Position Overview: We are seeking a highly organized, detail-oriented Documentation Specialist to support the processing and management of regulated product documentation within a large enterprise environment. This position will manage documentation requests from initial receipt through final approval within a document management system. The ideal candidate is a self-starter who is comfortable handling a high volume of documentation, managing multiple priorities, and ensuring documentation is processed accurately and within established timelines. Experience within a pharmaceutical, biotechnology, medical device, or other regulated/GxP environment is highly preferred. Location: Irvine, CA or Lake County, IL. Contract: 2 years, based on performance and business needs.

Responsibilities

• Process and manage GxP and controlled documents within an electronic document management system.
• Coordinate documentation requests from receipt through review, approval, and completion.
• Manage a high volume of documentation while ensuring accuracy, compliance, and adherence to established timelines.
• Maintain records in accordance with corporate record retention and archival policies and applicable GxP/GMP/GLP requirements.
• Track documentation status and proactively follow up with appropriate stakeholders to keep requests moving through the approval process.
• Support department record archival and retention activities.
• Assist with equipment purchasing, tracking, and follow-up as needed.
• Work effectively within a matrixed organization while managing shifting priorities and deadlines.
• Identify opportunities to improve documentation processes and workflows.
• Support process improvement initiatives, including potential applications of automation and AI/ML tools.

Qualifications

• High school diploma or equivalent required; additional education is welcome but not required.
• Approximately 3 years of relevant documentation, document control, records management, or quality documentation experience preferred; candidates with less experience may be considered based on the relevance of their background.
• Experience processing high volumes of documentation, particularly within a large enterprise environment, strongly preferred.
• GxP, GMP, or GLP documentation experience highly preferred.
• Experience with electronic document management systems required or strongly preferred.
• OneVault experience is highly preferred; Documentum experience is also strongly valued.
• Experience with Microsoft Office, particularly Word and Excel, required.
• Experience with DocXTool and/or PowerApps is a plus.
• Experience implementing process or workflow improvements is preferred.
• Strong organizational, communication, and attention-to-detail skills.
• Ability to independently execute tasks with minimal oversight.
• Ability to manage multiple priorities and follow documentation through to completion.

Pay

$28-$30/hour

Schedule

Hybrid - Monday & Friday remote; Tuesday-Thursday onsite. Candidates should have some schedule flexibility to occasionally support later working hours across European and U.S. time zones.