GMP-Driven Document Control & Change Specialist

bioMerieux; Collinsville (IL); On-site; USD 31,000 - 47,000; Full time

Benefits offered by this job

Medical, dental, and vision plans

Life and AD&D Insurance

Disability Insurance

Retirement plan with company match

Wellness Programs

Employee Assistance Program

Commuter Benefits

Voluntary benefits

Discount programs

Parental leaves

Job summary

bioMérieux is seeking a Detail-oriented Document Control Specialist to support the implementation and sustainability of Change Management and Quality documentation at the St. Louis site. You will manage document lifecycles, route reviews, and ensure compliant archival and retrieval of records across the quality system.

The role requires collaboration with multiple departments, rigorous attention to detail, and the ability to train staff on internal processes. Nearby travel is minimal.

Qualifications

• Bachelor's degree in STEM or related discipline (life sciences, engineering, Quality, Regulatory Affairs, or Information Systems) is required.
• In lieu of a Bachelor's degree, 4 years of additional relevant experience will be accepted.
• 2+ years of Quality or Document Specialist experience in a GMP environment preferred.
• Experience with TrackWise Digital and SAP is preferred but not required.
• Strong written communication skills and attention to detail are required.

Responsibilities

• Monitor the change process to ensure only approved and validated changes are in released product documentation.
• Train new employees and internal customers on internal processes.
• Collaborate with cross-functional departments to ensure timely implementation of change controls.
• Facilitate timely procedure updates with process owners.
• Route documents for review, approval and ensure completion of the approval process.
• Own the site Periodic Review process to ensure procedures are reviewed and updated accordingly.
• Reviews and distributes documents and correspondence.
• Maintain accurate filing systems.
• Perform data entry and prepare quality system records documents.
• Archive and retrieve records per established procedures.
• Organize transfer of documentation to/from offsite storage as needed.
• Walk within the campus to transfer documentation.
• Organize meetings and appointments.
• Support internal and external audit activities.
• Support quality projects with departments and the facility, as needed.

Skills

Written communication

Attention to detail

Time management

Multitasking

Troubleshooting

MS Office

Education

Bachelor's degree in STEM

4 years of relevant experience in lieu of degree

Tools

TrackWise Digital

SAP

Job description

bioMérieux is seeking a Detail-oriented Document Control Specialist to support the implementation and sustainability of Change Management and Quality documentation at the St. Louis site. You will manage document lifecycles, route reviews, and ensure compliant archival and retrieval of records across the quality system.

The role requires collaboration with multiple departments, rigorous attention to detail, and the ability to train staff on internal processes. Nearby travel is minimal.