Job Summary

The Operations Coordinator in Template Control runs logistics for the production team which formulates DNA and RNA control components to support the company’s in vitro diagnostic products’ research and development, manufacturing, validations, and quality control efforts. Principle responsibilities include planning, scheduling, and coordinating Template Control parts through the production cycle with the goal of maximizing efficiency and eliminating issues and interruptions, ensuring comprehensive compliance with materials requirements for manufacturing, supporting document revisions required for manufacturing and operations processes, and communicating between various groups and departments to properly prepare production orders per schedule requirements. Exceptional organizational and communication skills, attention to detail and commitment to bioMérieux’s corporate culture are essential to successfully fulfill this role.

Essential Job Duties and Responsibilities

1. Perform all work in compliance with company policy and within the guidelines of bioMérieux’s Quality System.
2. Plans, prepares, issues, controls and revises the production schedule for products or subassemblies associated with the Template Control work center, ensuring an optimal flow of work through interdependent product centers.
3. Interfaces with databases and spreadsheets to compile and maintain reports concerning progress of work and failures throughout the production process and to track production units.
4. Maintain FilmArray Pilot product tracking spreadsheets/software.
5. Works with Materials Management, Inventory Control, Purchasing, Manufacturing Engineering Support, QA, R&D and Template Control to ensure necessary materials are available and inspections are performed in preparation for scheduled manufacture events.
6. Works with Manufacturing Engineering Support, QA and Template Control to coordinate calibration, preventative maintenance, service, and repair for all Template Control equipment and instrument assets.
7. Assist as directed by management with resolving process/product related issues using tools such as temporary deviations, rework procedures, NCRs, etc.
8. Work closely with Template Control Production Manager and Template Control Project Managers to implement improvements to manufacturing processes including planning, sourcing and coordinating improvement-related solutions.
9. Identify and communicate possible workflow issues to Template Control Production Manager and Template Control Project Managers in order to minimize impact on product release.
10. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Generally receives little instruction on routine work and general instructions on new assignments.
11. Exhibits a high level of organization and tremendous attention to detail in order to successfully execute technical high cost manufacturing events.
12. Perform additional tasks as assigned.Supplemental Data

1. Coordination of the Template Control work center within the FilmArray product workflow is critical and fast paced. Sales and customer service can be directly affected without strong manufacturing scheduling and Template Control product inventory. Must be able to communicate and identify issues effectively.
2. Document revision will require attention to detail and strong technical writing skills.
3. Project and production coordination within a fast-paced environment.

Qualifications

Training and Education

Minimum – A.S. Degree and 6 years related experience.
Preferred – B.A. or B.S. in a Life Science or Manufacturing/Business Operations, or related field.
Preferred – Certification in Lean, Six Sigma, CPIM and/or APICS.

Experience

At least 2 years’ experience working in a cGMP/FDA/ISO manufacturing facility preferred.
Familiarity with PCR and its variants desired.

Knowledge, Skills and Abilities

• Demonstrated understanding of inventory control and electronic MRP systems and intermediate proficiency using Excel or other Microsoft applications.
• Analytical and planning skills associated with optimizing a production environment.
• Ability to communicate clearly and effectively and have strong attention to detail, organization, and multitasking skills.
• Ability to shift priorities and meet required deadlines and manage numerous priorities simultaneously with minimal supervision.
• Demonstrate high-level of business judgment and clear communication with cross-functional teams and others at all levels of the organization.

Physical Requirements

Must be capable of sitting for long periods of time.