Sterilization Center of Excellence QC Lab Supervisor

Requisition Number: 66427

 

Corning is vital to progress – in the industries we help shape and in the world we share.

 

We invent life-changing technologies using materials science. Our scientific and manufacturing expertise, boundless curiosity, and commitment to purposeful invention place us at the center of the way the world interacts, works, learns, and lives.

 

Our sustained investment in research, development, and invention means we’re always ready to solve the toughest challenges alongside our customers. 

As a leading developer, manufacturer, and global supplier of scientific laboratory products for 100 years, Corning’s Life Sciences segment collaborates with researchers seeking new approaches to increase efficiencies, reduce costs and compress timelines in the drug discovery process. Using unique expertise in the fields of materials science, surface science, optics, biochemistry and biology, the segment provides innovative solutions that improve productivity and enable breakthrough discoveries.

Role Purpose

Facilitate and direct daily quality control testing laboratory activities to ensure control and compliance to established laboratory process controls and operating procedures.  Achieve department requirements for safety, quality, product release, testing turnaround time, sample throughput, and cost. Ensures goods are tested according to approved procedures and standards.

 

Serves as subject matter expert for compliance to all relevant regulatory standards within the QC Laboratory.  Applies expertise to problem solving, guiding/coaching others, developing experimental designs, equipment and method validations and new method development.  Identifies and drives process improvement while monitoring, communicating, and championing best practices. 
 

Responsibilities

• Schedules resources and prioritizes quality control testing laboratory activities to ensure efficient and timely execution.
• Support and may lead multiple sterilization assurance and laboratory standardization projects within the division and applicable plants.
• Supports activities related to product changes impacting sterilization equipment/processes and the associated laboratory/functional testing required as part of the validations.
• Writes, executes (as applicable), and provides guidance on validations for equipment and new/revised testing methods.
• Provides daily direction to QC Technicians.
• Communicates and reports performance metrics.  Ensures that testing turnaround targets, right the first time and other established metrics are met on a daily, weekly, and monthly basis.
• Performs performance reviews and develops and reinforces career and talent development plans for QC Technicians.
• Develops, implements, and monitors development programs, training, qualification, and certifications for new and experienced laboratory technicians.
• Communicates company information to technicians within QC and provides regular meeting opportunities for direct reports.
• Accountable for out-of-specification (OOS) investigations, invalid reports, CAPA, root cause analysis, and continuous improvement initiatives.
• Authors/revises and reviews SOPs.  Monitors and identifies opportunities for procedure improvement to improve compliance, efficiency, and technical accuracy of the department. Drives recommended improvements through to completion.
• Ensures the laboratory personnel are operating in compliance to operating procedures and established safety and training programs.
• Maintains regulatory compliance for the QC laboratory including FDA, ISO, and testing methods.
• Reviews proposed new products and determines appropriate testing and specification requirements or confirms capabilities are available and specifications are appropriate.
• Accountable for compliance to laboratory calibration, validation, stability/retention, and preventive maintenance programs.
• Accountable for QC method development, transfer, and validation.
• Ensures compliance to department spending and budgets.

Requirements

• Bachelor’s degree required; prefer program in Sciences such as microbiology, chemistry, biology or related science fields.
• Minimum of 5+ years of laboratory experience in a highly regulated industry; strongly prefer medical device or pharmaceutical.
• Direct experience in sterility assurance or product sterilization a plus.
• Experience with laboratory practices, microbiological testing methods and va