The Production Coordinator organizes and prepares work within a manufacturing group. Follows a production schedule to coordinate and organize resources necessary for production work orders and to ensure production flows smoothly and efficiently. Creates production batch records, prints/prepares labels, and gathers assigned materials lots for production orders. Participates in cycle counts, delivery of QC samples, and delivery/transaction of R&D materials. Ensures comprehensive compliance for proper documentation of batch records and material requirements for the production staff. Interfaces between production departments and with production schedulers, materials management, QA, and R&D to properly prepare the production orders per schedule requirements. Communicates any potential scheduling issues to the affected groups, and works with the production schedulers and scheduling manager to resolve scheduling issues. Monitors inventory status of production sub-assemblies critical to the manufacturing process, and communicates potential shortages to the production scheduler. Collects, reviews, and inputs data into databases. Has knowledge of commonly used concepts, practices and procedures within cGMP reagent manufacturing. Normally receives general instruction on routine work and detailed instruction on new assignments. The Production Coordinator may participate in process improvements and other documentation efforts. Performs work in compliance with company policy and within the guidelines of BioFire Diagnostics Quality System.

PLEASE NOTE: The working schedule will be B Shift, every other Wednesday 6:00 AM – 6:00 PM + all Thursday - Saturday 6:00AM - 6:00PM.

Principal Job Duties and Responsibilities:

• Perform all work in compliance with company policy and within the guidelines of its Quality System.

• Responsible for assisting Team Leads, Supervisors, & Managers with technical issues such as troubleshooting production issues, organization workflow, scheduling and batch records issues, and ensuring correct raw materials are being consumed.

• Assist teams with technical support issues such as manufacturing specialized orders and coordinating the delivery and consumption of special R&D materials.

• Assists as directed by management with resolving process/product related issues using tools such as Temporary Deviations, rework procedures, NCR’s, etc.

• Generate and maintain records as required by the Quality System.

• Evaluates the master production schedule and issues production batch records.

• Works with Materials Management, QA, R&D and within production departments to ensure necessary materials are available and inspections are performed in preparation for scheduled manufacture events.

• Ensures digital and paper records are properly maintained, providing general support and assistance with documentation issues and corrections.

• 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.

• Responsible for ordering Kanban items and maintaining stocks of critical raw materials and sub-assemblies, including monitoring of expiration dates.

• Responsible for coordinating the testing of critical raw materials and subassemblies.

• Maintain organization and cleanliness of assigned work area(s).

• Participates in projects relating to process improvements for reliability and increased capacity.

• Perform additional tasks as assigned by management.

• Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR).

Minimum Qualifications

Training & Education: High School Diploma required. Bachelor’s degree in a Biology/Chemistry or Supply Chain field is preferred.

Experience: Prior cGMP/FDA/ISO manufacturing experience is required. Prior experience in manufacturing reagents is preferred. Demonstrated working knowledge of PCR is preferred.

Skills: Must have a demonstrated understanding of inventory control and electronic MRP systems and intermediate proficiency using Excel and other Microsoft applications. Must be able to assign and transcribe numerical data associated with assigning and tracking lot numbers. Must be able to use mathematical skills to assess materials availability and assignment to job orders and assess inventory, throughput and yield performance. Must be able to communicate clearly and effectively and have strong attention to detail, organizational, and multitasking skills.

Physical Requirements: Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR).

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