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Position Summary

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. Maintain quality records including filing, preparing documents for scanning and shredding of documents per procedure and provide input regarding the continuous improvement of each.

Primary Duties

+ Execute quality projects by applying engineering principles and business standards, ensuring compliance with project requirements while collaborating with technical quality experts.

+ Ensure thorough documentation of technical data generated for projects, adhering to applicable quality directives and procedures.

+ Document and maintain quality systems and programs to align with local and global regulatory requirements and corporate quality standards.

+ Lead initiatives that support Quality Management System (QMS) compliance, including CAPA management, change control, supplier quality assessments, and internal audits.

+ Develop, review, and approve qualification and validation protocols, while providing regular updates on project status and communicating significant developments.

+ Monitor the change process so that only approved and validated changes are incorporated in released product documentation.

+ 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.

+ Reviews and distributes documents and correspondence.

+ Maintains accurate filing systems.

+ Performs data entry and prepares a variety of documents, related to quality system records.

+ Perform all work in compliance with company quality procedures and standards.

+ Performs other duties as assigned.

Qualifications and Experience

+ The role requires High School Diploma, GED or Equivalent but prefers an Associate's Degree

+ 5 years of document review experience with beginner's experience in a Quality /GMP environment (medical device preferred), including strong computer skills such as Microsoft Office Package (Excel, Word, etc.). Experience with Trackwise Digital and SAP would be an advantage

Knowledge, Skills, and Abilities

+ 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

+ Comfortable giving clear, direct, and actionable feedback

+ Effective verbal communication skills

+ Easily accessible and open to communication

+ Participate in a way that enhances team performance and cohesion.

+ Consistently uphold and reflects the core ethical principles and values that bioMérieux promotes

Working Conditions and Physical Requirements

+ Ability to ascend/descend stairs, ladders, ramps, and the like.

+ Ability to adjust or move objects up to 50 pounds in all directions.