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Description

Position Summary:

Manage the personnel, material resources, and operations of the Final Quality Control Reagent Laboratory.  Responsible for ensuring departmental compliance with all regulations, quality systems, internal and external customer requirements.   Develop, implement, and monitor the performance of Final Quality laboratory processes, metrics, personnel, and testing methods to ensure reagents conformance.

Primary Duties:

1. Develop and maintain quality performance metrics for the laboratory to provide management a method of assessing the effectiveness of production processes, current specifications, test methods, and personnel performance.  
2. Oversees the performance testing functions, ensuring efficiency to meet production demands and continuous improvement of laboratory performance.  As applicable, oversee the physical inspection of production cards, cartons, and pouches. 
3. Assists Lab Technicians in prioritizing to ensure schedule is met. 
4. Develop and implement departmental operational procedures to ensure regulatory compliance within the laboratory (FDA, GMP, ISO, CLIA, OSHA, etc.). 
5. Make recommendations for improving quality & productivity performance, offer troubleshooting expertise, and conduct quality improvement studies where appropriate. 
6. Lead efforts to ensure continuous product and process improvement in areas of responsibility. 
7. Ensure the quality of finished goods and materials to maximize the utilization of resources to meet goals.  Ensure timeliness and efficiency of goods and material testing. 
8. Responsible for developing and maintaining regular Quality Control trend data and reports.   
9. Works with other departments to ensure operational and quality goals are understood and met.   
10. Provide methods to communicate the quality status of materials and processes to internal customers, management, and external suppliers. 
11. Monitor and maintain departmental personnel meet commitments / deadlines.  Lead team members by establishing performance criteria, providing training and resources, giving regular coaching, feedback and guidance. Ensures an engaged and skilled workforce through active listening and communication. 
12. Manages Reserve Samples and ensures the sampling and testing of Environmental Monitoring samples are performed accurately and timely. 
13. Acts as immediate backup to Sr. QC Manager functions, including regular presentations at group meetings. 
14. Support QC and other projects and participates on special teams as requested by management. Performs testing and physical inspections per product procedure, as needed.
15.  Makes decisions based primarily on defined guidelines and procedures, but responsible for the direction of others, as well as scheduling work to meet demands and deadlines.  Must perform troubleshooting to determine cause of problem areas.  Must problem solve to ensure employee conflict resolution. 

Position Requirements:

Bachelor’s degree in biology or related field or acceptable experience (8 years relevant lab experience in lieu of degree)

3+ years progressively responsible experience in microbiology lab work, performing varied testing and troubleshooting activities in high volume environment. 

1+ year supervisory experience.  At a minimum, must demonstrate the ability to lead others by building relationships, provide coaching and feedback to employees, and delegate assignments as needed to ensure efficient work production.  

Proven excellent verbal and written communication skills are a must as this position interacts at all levels of the organization and acts as immediate back-up to the Sr. QC Manager as needed 

Requires advanced knowledge of QC systems, practices, and procedures including microbiological, testing, and inspection processes. 

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

Must have a strong knowledge of GMP, ISO, and FDA compliance

BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).