Quality Documentation & Change Control Specialist

bioMerieux; O’Fallon (MO); 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

Job summary

bioMérieux is seeking a document control specialist at our St. Louis site to support the Change Management program and quality documentation lifecycle.

The role ensures only approved changes are reflected in released product documentation and collaborates with cross-functional teams to meet regulatory and customer requirements. The successful candidate will train colleagues, manage filing and archiving, and support internal/external audits while maintaining accuracy in quality system records and

Qualifications

• Bachelor degree in STEM or related discipline such as Quality, Regulatory Affairs, or Information Systems.
• Education Substitution: 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.

Skills

Detail orientation

Time management

Multitasking

Strong written communication

Education

Bachelor's degree in STEM

4 years of additional relevant experience

Tools

TrackWise Digital

SAP

MS Office

Job description

bioMérieux is seeking a document control specialist at our St. Louis site to support the Change Management program and quality documentation lifecycle.

The role ensures only approved changes are reflected in released product documentation and collaborates with cross-functional teams to meet regulatory and customer requirements. The successful candidate will train colleagues, manage filing and archiving, and support internal/external audits while maintaining accuracy in quality system records and