Document Control Specialist

Document Control Specialist

Laboratory

Chicago, Illinois, US

Added - 11/06/2026

Pay Rate Low: 65000 | Pay Rate High: 65000

• Provide daily administrative support to the Manufacturing Manager, including scheduling, coordination of activities, and preparation of reports
• Facilitate communication between Manufacturing and cross-functional departments such as Quality Assurance, Quality Control, Supply Chain, and Facilities
• Draft, revise, and review controlled GMP documents including Standard Operating Procedures (SOPs), batch records, and training materials
• Ensure document accuracy, compliance, and alignment with internal quality standards and applicable regulatory requirements
• Manage document routing, approval workflows, version control, and archival within the documentation management system
  
  Support Corrective and Preventive Action (CAPA) activities, including data collection, documentation, tracking, and follow up.
• Assist with investigations by gathering relevant data, compiling summaries, and supporting root cause analysis efforts.
• Provide hands‑on support in cleanroom operations during periods of increased demand, staffing gaps, or special projects. Cleanroom operational support may require working 1st shift or 2nd shift.

• Bachelor’s degree in a scientific field
• Background in Manufacturing, Process Engineering, MSAT, Technical Services, or Quality Assurance preferred
• At least 2 years of related experience in a GMP manufacturing environment, pharmaceuticals or biosimilars preferred

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.