"Alerted.org

Position Summary:

The Production Coordinator 2 manages product movement across all work centers in Reagent Manufacturing and QC to ensure product flow is not disrupted. Responsible for NCR movement and visibility, coordinates with manufacturing work centers, engineering, QA, QC, BioMath, etc. to ensure NCRs and RNDs are completed in a timely manner. Participates with Continuous Improvement team for NCR/RND process improvement projects. Tracks and manages visibility of validation lots. Communicates product movement, NCR/RND status, and validation lot status across shifts and within scheduling team. Assists with the management and filling of internal orders. Manages Buffer 1A scheduling and coordination within BioFire and participates in communication with the vendor related to the production schedule. 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 coordinate product movement. Communicates any potential scheduling issues to the affected groups, and works with the production schedulers and scheduling manager to resolve scheduling issues. Collects, reviews, and inputs data into databases. Normally receives general instruction on routine work and detailed instruction on new assignments. The Production Coordinator 2 may participate in process improvements and other documentation efforts.

Primary Duties:

1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.

2. Responsible for managing and communicating product movement across all work centers in Reagent Manufacturing and QC.

3. Manages NCR/RND visibility and coordinates with cross-functional group to ensure NCR/RNDs are completed on time.

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

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

6. Evaluates the master production schedule and communicates any potential impacts or delays related to product movement to impacted groups.

7. 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.

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

9. 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.

10. Responsible for managing and coordinating the Buffer 1A manufacturing process.

11. Assists with tracking, filling, and closing of internal sales orders.

12. Assists with the tracking of validation builds and the communication regarding timelines and impacts to production.

13. Cross train in main responsibilities of and provide back-up support for Coordinator 1 position.

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

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

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

17. Performs other duties as assigned.

Training, Education and Experience:

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

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

Knowledge, Skills and Abilities:

1. Must have a demonstrated understanding of inventory control and electronic MRP systems and intermediate proficiency using Excel and other Microsoft applications.

2. Must be able to assign and transcribe numerical data associated with assigning and tracking lot numbers.

3. Must be able to communicate clearly and effectively and have strong attention to detail, organizational, and multitasking skills.

4. Has knowledge of commonly used concepts, practices and procedures within cGMP reagent manufacturing.

Physical Requirements:

+ Ability to remain in a stationary position, often standing, for prolonged periods.

+ Ability to wear PPE correctly for most of the day.

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