GMP Document Control & Change Specialist

bioMerieux; St. Louis (MO); On-site; USD 31,000 - 47,000; Full time

Benefits offered by this job

Medical/Dental/Vision plans

Bonus program

Life Insurance

Disability Insurance

Retirement Plan with employer match

Wellness Programs

Employee Assistance Program

Commuter Benefits

Voluntary benefit offerings

Discount programs

Parental leaves

Job summary

bioMérieux Saint Louis seeks a skilled Document Control Specialist to support implementation and sustainability of Change Management and GMP documentation within the Quality System. You'll train staff, route documents for review, maintain filing, and ensure archival and retrieval per procedures while collaborating with cross-functional teams to drive timely updates and audit readiness.

Domestic travel is minimal; the role demands attention to detail, strong communication, and the ability to

Qualifications

• Bachelor's degree in a STEM field (life sciences or engineering) or related discipline such as Quality, Regulatory Affairs, or Information Systems.
• 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 preferred, but not required.
• Strong written communication skills and attention to detail are required.
• Ability to inspire, motivate, and build the confidence within the team to reach goals, consistently pushing self and others to achieve results.

Responsibilities

• Monitor the change process so that 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.
• Responsible for facilitating 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 site procedures are reviewed and updated in accordance with their periodic review requirements.
• Reviews and distributes documents and correspondence.
• Maintains accurate filing systems.
• Performs data entry and prepares a variety of documents, related to quality system records.
• Responsible for the archival and retrieval of records in accordance with established procedures.
• Organize the transfer of documentation to and from the offsite storage facility, as needed.
• Ability to walk within the company campus to transfer documentation.
• Organizes meetings and/or appointments.
• Support internal and external audit activities.
• Support quality projects with departments and the facility, as needed.

Skills

Detail orientation

Time management

Multitasking

Communication

MS Office

Troubleshooting

Team motivation

Education

Bachelor's degree in STEM

4 years relevant experience

Tools

TrackWise Digital

SAP

Job description

bioMérieux Saint Louis seeks a skilled Document Control Specialist to support implementation and sustainability of Change Management and GMP documentation within the Quality System. You'll train staff, route documents for review, maintain filing, and ensure archival and retrieval per procedures while collaborating with cross-functional teams to drive timely updates and audit readiness.

Domestic travel is minimal; the role demands attention to detail, strong communication, and the ability to