Lonza Biologics, Inc.
QC Supervisor - Environmental Monitoring
Lonza Biologics, Inc., Portsmouth, Virginia, United States, 23703
Location
Portsmouth, NH, USA. The actual location of this job is in Portsmouth, NH, USA. Relocation assistance is available for eligible candidates and their families, if needed.
Lead a high-impact team dedicated to safeguarding the sterility and quality of our manufacturing environment through expert oversight of the Environmental Monitoring (EM) and Microbiology program.
What you will get
An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
Medical, dental and vision insurance.
Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits.
What you will do
Manage and supervise the QC Microbiology team responsible for routine and production environmental monitoring (EM), utility monitoring, and microbiology testing.
Act as the site Subject Matter Expert (SME) for the EM and Utility trend program, identifying adverse trends and presenting key trend information to the site Quality Council.
Oversee the investigation of environmental excursions, coaching the team through root cause analysis and ensuring corrective actions (CAPA) are implemented and monitored.
Review laboratory records for accuracy and strict compliance with cGMP and Lonza policies, ensuring the site remains in a permanent state of control.
Act as a technical advisor and mentor, holding routine one-on-ones and team meetings to drive performance management and staff development.
Represent the QC-EM department during internal and external regulatory audits, preparing technical responses to audit findings, deviations, and investigations.
Monitor QC resource capacity and department spending, providing regular reports to management on budget analysis, project updates, and team efficiency.
What we are looking for
Experience: Significant experience in a cGMP Quality Control Microbiology or Environmental Monitoring role, with proven leadership or supervisory capabilities.
Technical Expertise: Deep knowledge of environmental and utility monitoring programs, including establishment of sampling plans, trending, and excursion response.
Analytical Skills: Demonstrated ability to perform root cause investigations, manage deviations/CAPAs, and analyze complex trend data for quality reporting.
Education: Bachelor’s degree in Microbiology, Biology, or a related Science field is preferred; High School Diploma with extensive relevant experience is required.
Soft Skills: Exceptional mentorship and coaching skills, with the ability to provide feedback that drives both individual and team success.
Communication: Ability to give oral presentations to customers and management and write high-level technical documents, SOPs, and protocols.
About Lonza At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
#J-18808-Ljbffr
Lead a high-impact team dedicated to safeguarding the sterility and quality of our manufacturing environment through expert oversight of the Environmental Monitoring (EM) and Microbiology program.
What you will get
An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
Medical, dental and vision insurance.
Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits.
What you will do
Manage and supervise the QC Microbiology team responsible for routine and production environmental monitoring (EM), utility monitoring, and microbiology testing.
Act as the site Subject Matter Expert (SME) for the EM and Utility trend program, identifying adverse trends and presenting key trend information to the site Quality Council.
Oversee the investigation of environmental excursions, coaching the team through root cause analysis and ensuring corrective actions (CAPA) are implemented and monitored.
Review laboratory records for accuracy and strict compliance with cGMP and Lonza policies, ensuring the site remains in a permanent state of control.
Act as a technical advisor and mentor, holding routine one-on-ones and team meetings to drive performance management and staff development.
Represent the QC-EM department during internal and external regulatory audits, preparing technical responses to audit findings, deviations, and investigations.
Monitor QC resource capacity and department spending, providing regular reports to management on budget analysis, project updates, and team efficiency.
What we are looking for
Experience: Significant experience in a cGMP Quality Control Microbiology or Environmental Monitoring role, with proven leadership or supervisory capabilities.
Technical Expertise: Deep knowledge of environmental and utility monitoring programs, including establishment of sampling plans, trending, and excursion response.
Analytical Skills: Demonstrated ability to perform root cause investigations, manage deviations/CAPAs, and analyze complex trend data for quality reporting.
Education: Bachelor’s degree in Microbiology, Biology, or a related Science field is preferred; High School Diploma with extensive relevant experience is required.
Soft Skills: Exceptional mentorship and coaching skills, with the ability to provide feedback that drives both individual and team success.
Communication: Ability to give oral presentations to customers and management and write high-level technical documents, SOPs, and protocols.
About Lonza At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
#J-18808-Ljbffr