QS Document Control Specialist

bioMerieux; Saint Charles (MO); On-site; USD 31,000 - 47,000; Full time

Benefits offered by this job

Medical plans

Dental and Vision

Retirement plan with employer match

Disability insurance

Wellness programs

Employee Assistance Program

Commuter benefits

Discount programs

Parental leaves

Life insurance

Job summary

bioMérieux in Saint Charles, MO is seeking a Document Control & Change Management Support for the St. Louis site. The role ensures only approved changes are reflected in documentation, trains staff, and collaborates across functions to meet regulatory standards.

Responsibilities include maintaining quality records, routing documents for approvals, and supporting audits. Strong MS Office skills and TrackWise/SAP familiarity are valued. This is an on-site role with growth in quality systems.

Qualifications

• Bachelor's degree in a STEM field or related discipline such as Quality, Regulatory Affairs, or Information Systems.
• Alternatively, 4 years of additional relevant experience in lieu of degree.
• 2 years of GMP-quality or document specialist experience preferred.
• Experience with TrackWise Digital and SAP is a plus.

Responsibilities

• Monitor the change process to ensure only approved changes are in released product documentation.
• Train new employees and internal customers on internal processes.
• Collaborate with cross-functional departments to implement change controls on time.
• Facilitate timely updates of procedures with process owners.
• Route documents for review and ensure approvals are completed.
• Own the site periodic review process and ensure procedures are updated.
• Maintain accurate filing systems and archiving of records.
• Support internal and external audit activities.
• Assist quality projects across departments.

Skills

MS Office

TrackWise Digital

SAP

Time management

Detail oriented

Written communication

Team collaboration

Education

Bachelor's degree in STEM or related field

Education substitution: 4 years of relevant experience

Tools

TrackWise Digital

SAP

Job description

The purpose of this position is to support implementation and sustainability of the Document Control and Change Management programs at the St. Louis site. Facilitate creation, modification, and approval of changes via the site Change Management program. Support the lifecycle of documentation within the Quality System. Operates as a support function that collaborates with all local functions within the bioMerieux Inc., St. Louis facility. Ensures that quality documentation meets applicable customer, regulatory, and Company requirements. Ability to understand manufacturing specifications, requirements, procedures and departmental processes. Maintain quality records including filing, preparing documents for scanning and shredding of documents per procedure. Provide input regarding the continuous improvement of each. Support internal customers to ensure proper GMP compliance in editing and revising Quality records.

Working Conditions (Summary)

The role requires the ability to ascend and descend stairs, ladders, ramps, and similar structures, move objects up to 50 pounds, and regularly walk across the bioMérieux campus. Domestic travel is 0% and international travel is 0%.

Primary Duties

• 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.

Qualifications

• Bachelor degree required — Bachelor’s degree in a STEM field (life sciences or engineering) or a 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, defined below, 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.

Knowledge, Skills, and Abilities (KSAs)

• Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
• Detail orientation to complete tasks without errors and produce high-quality work.
• Thriving in a fast-paced environment by managing tasks, multitasking, and adapting quickly to maintain productivity.
• Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently.
• Troubleshooting issues to identify and resolve problems efficiently.
• Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel.
• Intermediate: applies skills independently in most situations; handles moderately complex tasks with occasional guidance.
• Experience with Trackwise Digital and SAP would be an advantage.

The pay range for this role in the state of Missouri is $22.50/hr to $34/hr. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMérieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.

A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options

Company-Provided Life and Accidental Death Insurance

Short and Long-Term Disability Insurance

Retirement Plan including a generous non-discretionary employer contribution and employer match.

Wellness Programs

Employee Assistance Program

Commuter Benefits

Various voluntary benefit offerings

Discount programs

Parental leaves

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Location/Region: Saint Charles, MO (63302)