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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. 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.

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 which includes 6 buildings 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-Knowledge, Experience & Skills:

+ Requires an Associates Degree and 2 years of quality/document review experience in a GMP environment (medical device preferred) OR in lieu of an Associates Degree, 4 years of quality/document review experience in a GMP environment (medical device preferred).

+ Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).

+ Strong written communication skills and attention to detail are required.

+ Must have sound knowledge of regulatory requirements such as ISO, FDA, etc.

+ Ability to proficiently use Microsoft Office Tools.

+ Ability to inspire, motivate, and build the confidence within the team to reach goals, consistently pushing self and others to achieve results.

+ Ability to influence peers, managers and internal customers of Document Control.

+ Must demonstrate team leadership skills.

+ Ability to work both independently and in a team environment.