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Position Summary & Responsibilities: 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. Provide coaching, feedback, guidance, and training to employees, ensuring an engaged and skilled staff.

+ Develop and maintain quality performance metrics for the laboratory to provide management a method of assessing defect patterns/trending and associated lot set-up issues.

+ 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.

+ Assists Lab Technicians in prioritizing to ensure schedule is met.

+ Develop and implement departmental operational procedures to ensure regulatory compliance within the laboratory (FDA, GMP, ISO, CLIA, OSHA, etc.).

+ Make recommendations for improving quality & productivity performance, offer troubleshooting expertise, and conduct quality improvement studies where appropriate.

+ Lead efforts to ensure continuous product and process improvement in areas of responsibility.

+ 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.

+ Oversee and monitor QC testing that is part of the site instrument release program.

+ Support and collaborate on environmental monitoring with the QC Micro team.

+ Works with other departments to ensure operational and quality goals are understood and met.

+ Provide methods to communicate the quality status of materials and processes to internal customers, management, and external suppliers.

+ 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.

+ Collaborate with the QC Micro group, Quality on Floor, and Quality Release team.

+ Support QC and other projects and participates on special teams as requested by management.

+ Performs testing and physical inspections per product procedure, as needed

Education, Skills, & Experience:

+ Bachelor's degree required, in a scientific or technical field preferred, with 3+ years of progressively responsible experience in a laboratory or quality inspection area, performing varied testing and troubleshooting activities in high volume environment.

+ 1+ year supervisory experience is highly preferred.

+ 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

+ Technical writing skills preferred

+ Knowledge of VITEK2 cards and instrument operation and troubleshooting preferred

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