QS Document Control Specialist

About the Role

This position supports the implementation and sustainability of the Document Control and Change Management programs at the St. Louis site. The role facilitates creation, modification, and approval of changes via the site Change Management program and supports the lifecycle of documentation within the Quality System. It operates as a collaborative support function across all local functions within the bioMérieux Inc., St. Louis facility, ensuring quality documentation meets applicable customer, regulatory, and company requirements.

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 and international travel is 0%.

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 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.
• Review and distribute documents and correspondence.
• Maintain accurate filing systems.
• Perform data entry and prepare 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.
• Support internal and external audit activities.
• Support quality projects with departments and the facility, as needed.

Requirements

• 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 will be accepted.
• 2 years of quality/document review experience in a GMP environment.
• Experience with TrackWise Digital and SAP preferred, but not required.
• Strong written communication skills and attention to detail.
• Ability to inspire, motivate, and build confidence within the team to reach goals.

Skills

• 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.
• Thrives in a fast-paced environment by managing tasks, multitasking, and adapting quickly to maintain productivity.
• Practices time management to allocate tasks, balance priorities, and meet deadlines efficiently.
• Troubleshoots issues to identify and resolve problems efficiently.
• Effective verbal communication skills.
• Skilled in MS Office tools including Outlook, Teams, Word, and Excel (intermediate level: applies skills independently in most situations; handles moderately complex tasks with occasional guidance).

Pay

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. Actual compensation within this range is determined based on the successful candidate’s experience.

Benefits

• 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.
• Adoption assistance.
• Wellness programs.
• Employee assistance program.
• Commuter benefits.
• Various voluntary benefit offerings.
• Discount programs.
• Parental leaves.