Quality Documentation & Change Control Specialist

bioMerieux; Wentzville (MO); On-site; USD 47,000 - 71,000; Full time

Benefits offered by this job

Medical, Dental & Vision plans

Life and AD&D Insurance

Disability Insurance

Retirement Plan with employer match

Job summary

bioMérieux is seeking a Documentation Control & Change Management Specialist at our St. Louis area facility to support implementation and ongoing operation of the Quality System documentation.

You will manage change control lifecycle, train staff, and collaborate with cross-functional teams to ensure timely updates and approvals. The role emphasizes maintaining accurate quality records, aiding audits, and ensuring regulatory compliance.

Qualifications

• Bachelor degree in a STEM field (life sciences or engineering) or related discipline such as Quality, Regulatory Affairs, or Information Systems.
• Education substitution: 4 years of additional relevant experience accepted in lieu of a Bachelor's degree.
• 2 years of Quality or Document Specialist experience in a GMP environment preferred.

Responsibilities

• Monitor the change process to ensure only approved and validated changes are incorporated 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 procedure updates in a timely fashion with process owners.
• Route documents for review, approval and assure completion of the approval process.
• Own the site Periodic Review process ensuring procedures are reviewed and updated.
• Review and distribute documents and correspondence.
• Maintain accurate filing systems.
• Perform data entry and prepare documents related to quality system records.
• Archive and retrieve records per procedures.
• Transfer documentation to/from offsite storage facility 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

Detail oriented

Strong written communication

Time management

Multitasking

Adaptability

Troubleshooting

MS Office proficiency

Education

Bachelor’s degree in STEM

4 years of additional relevant experience

Tools

TrackWise Digital

SAP

MS Office

Job description

bioMérieux is seeking a Documentation Control & Change Management Specialist at our St. Louis area facility to support implementation and ongoing operation of the Quality System documentation.

You will manage change control lifecycle, train staff, and collaborate with cross-functional teams to ensure timely updates and approvals. The role emphasizes maintaining accurate quality records, aiding audits, and ensuring regulatory compliance.