Documentation Specialist

About the role

This is a 6-month contract position in Abbott Park, IL, with potential to extend based on performance and continued need. Pay is $26–$28 per hour (W2).

Responsibilities

• Review and process document change request packages for policies, procedures, product specifications, manufacturing, packing/testing, and quality system documents.
• Ensure document changes are properly documented, justified, reviewed, and approved according to established procedures.
• Support document control and change control processes within a regulated manufacturing environment.
• Work with change request initiators and approvers to identify and resolve discrepancies.
• Maintain controlled documents and data in accordance with SOPs and quality-system requirements.
• Utilize document management and change control systems for document review, cross-referencing, approval, and distribution.
• Provide guidance and support to stakeholders regarding document management, QSD structure, and change control procedures.

Qualifications

• Bachelor’s or Associate’s degree required.
• 2+ years of experience in document control, change control, quality, compliance, manufacturing, regulatory, or a related function within a regulated industry.
• Experience in pharmaceutical, medical device, nutrition, biotech, or healthcare manufacturing preferred.
• Hands-on experience reviewing and processing document change requests, change orders, document revisions, approvals, and controlled documents.
• Working knowledge of cGMPs, quality systems, SOPs, and regulated documentation practices.
• Strong documentation review, proofreading, and attention-to-detail skills, including reviewing numerical values, equations, and technical information.
• Ability to resolve documentation discrepancies and ensure changes align with plant, division, and corporate guidelines.