Quality Control Manager Chemistry
4 weeks ago
As a Quality Control Manager Chemistry at Bristol-Myers Squibb, you will be responsible for leading the day-to-day operations of the laboratory, including on-time testing, analysis of data and trends, investigations, staff training, and equipment maintenance and calibration. You will also develop and supervise staff schedules to meet workflow demands, perform data review, trending analyses, and prepare protocols and reports to support all areas of laboratory operations. Additionally, you will be responsible for cGMP compliance in all aspects of assigned laboratory operations, provide technical and operational expertise for training and developing staff, and assist in troubleshooting. You will also perform or lead investigations for out of specification results, recruit and develop a high-performing team with diverse backgrounds and talents, and coach direct reports to evaluate and execute continuous improvement, develop their skill sets, and create an environment of continuous learning, improvement, and innovation. Furthermore, you will maintain and communicate team performance metrics, provide technical leadership to QC lab, serve as a Subject Matter Expert in cross-functional/cross-departmental work teams, and participate in the site team supporting and managing regulatory inspections and findings. This role requires a strong understanding of science, with a BS in physical or life sciences, and a minimum of 4-6 years of experience in a cGMP laboratory with 1-2 years of leadership experience. You will also have expertise and operational knowledge of equipment and test methods associated with Spectrophotometry, Appearance testing, and Karl-Fisher methods, as well as extensive knowledge of regulatory requirements and industry best practices. Prior experience supporting regulatory agency inspections is preferred, and experience with LIMS and ELN computer applications is a plus.
Responsibilities
• Lead the day-to-day operations of the laboratory, including on-time testing, analysis of data and trends, investigations, staff training, and equipment maintenance and calibration.
• Develop and supervise staff schedules to meet workflow demands.
• Perform data review, trending analyses, and prepare protocols and reports to support all areas of laboratory operations.
• Ensure cGMP compliance in all aspects of assigned laboratory operations.
• Provide technical and operational expertise for training and developing staff, and assist in troubleshooting.
• Perform or lead investigations for out of specification results.
• Recruit and develop a high-performing team with diverse backgrounds and talents.
• Coach direct reports to evaluate and execute continuous improvement, develop their skill sets, and create an environment of continuous learning, improvement, and innovation.
• Maintain and communicate team performance metrics.
• Provide technical leadership to QC lab, serve as a Subject Matter Expert in cross-functional/cross-departmental work teams, and participate in the site team supporting and managing regulatory inspections and findings.
Requirements
• BS in physical or life sciences.
• Minimum of 4-6 years of experience in a cGMP laboratory with 1-2 years of leadership experience.
• Expertise and operational knowledge of equipment and test methods associated with Spectrophotometry, Appearance testing, and Karl-Fisher methods.
• Extensive knowledge of regulatory requirements and industry best practices.
• Prior experience supporting regulatory agency inspections is preferred.
• Experience with LIMS and ELN computer applications is a plus.
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