Quality Documentation & Change Control Specialist

bioMérieux SA; Hazelwood (MO); On-site; USD 31,000 - 47,000; Full time

Benefits offered by this job

Medical, dental, vision plans

Life Insurance

Disability Insurance

Retirement Plan

Adoption Assistance

Wellness Programs

Commuter Benefits

Job summary

bioMérieux is seeking a Documentation Control Specialist at the St. Louis site to support implementation and sustainability of the Document Control and Change Management programs. The role ensures quality documentation meets customer, regulatory, and company requirements, and collaborates with cross-functional teams within bioMérieux Inc., St.

Louis. The candidate will maintain quality records, train staff, and facilitate timely updates to procedures while supporting internal audits and archival

Qualifications

• Bachelor degree in STEM or related field; or 4 years of additional relevant experience.
• 0-2 years of GMP quality or documentation experience preferred.
• Strong written communication and attention to detail required.
• Experience with TrackWise Digital and SAP preferred but not required.

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 timely updates to procedures with process owners.
• Route documents for review, approval and 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 quality system records.
• Archive and retrieve records per procedures.
• Organize transfer of documentation to/from offsite storage.
• Walk the campus to transfer documentation.
• Organize meetings and appointments.
• Support internal and external audit activities.
• Support quality projects with departments and the facility.

Skills

Detail orientation

Time management

Verbal communication

Multitasking

Education

Bachelor's degree in STEM

4 years of relevant experience

Tools

TrackWise Digital

SAP

Microsoft Excel

Microsoft Word

Microsoft Outlook

Microsoft Teams

Job description

bioMérieux is seeking a Documentation Control Specialist at the St. Louis site to support implementation and sustainability of the Document Control and Change Management programs. The role ensures quality documentation meets customer, regulatory, and company requirements, and collaborates with cross-functional teams within bioMérieux Inc., St.

Louis. The candidate will maintain quality records, train staff, and facilitate timely updates to procedures while supporting internal audits and archival