Quality Document Controller & Change Leader

bioMerieux Inc.; Hazelwood (MO); On-site; USD 30,000 - 47,000; Full time

Benefits offered by this job

Medical plans

Life Insurance

Disability Insurance

Retirement Plan

Adoption Assistance

Wellness Programs

Employee Assistance Program

Commuter Benefits

Voluntary Benefits

Discount Programs

Parental Leaves

Job summary

bioMerieux Inc. is seeking a Document Control and Change Management support specialist at the St. Louis site to sustain and improve quality documentation under GMP.

You will manage changes, train staff, and collaborate cross-functionally to ensure timely change implementation and proper archival of records across the quality system. The role requires strong attention to detail, excellent communication, and the ability to navigate site procedures and process owners.

Qualifications

• Bachelor degree in a STEM field or related discipline such as Quality, Regulatory Affairs, or Information Systems.
• Education substitution: 4 years of relevant experience accepted in lieu of a degree.
• No previous experience required.
• 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 confidence within the team to reach goals.

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 oriented

Strong written communication

Time management

Verbal communication

MS Office

Education

Bachelor's degree in STEM fields

4 years relevant experience (substitution)

Tools

TrackWise Digital

SAP

Job description

bioMerieux Inc. is seeking a Document Control and Change Management support specialist at the St. Louis site to sustain and improve quality documentation under GMP.

You will manage changes, train staff, and collaborate cross-functionally to ensure timely change implementation and proper archival of records across the quality system. The role requires strong attention to detail, excellent communication, and the ability to navigate site procedures and process owners.