QC Supervisor Cell Therapy

2 weeks ago


Portsmouth, United States Lonza Full time

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.Manages the QC Microbiology team which is responsible for environmental monitoring (routine and production), utility monitoring, and microbiology testing such as gram stain. Responsible for oversight of the environmental monitoring (EM) program including establishment of sampling plans, routine trending, and excursion response procedures in accordance with applicable regulatory guidelines and Lonza policy.Responsible for supervision of the Environmental Monitoring team. Acts as an advisor to subordinates when determining how to meet schedules and/or resolve technical problems.Reviews testing and laboratory records for accuracy and compliance with cGMP and Lonza policies and principles. Responsible for development of site Environmental and Utility monitoring programsand policies. Ensures sampling plans are up to date and executed as planned. Owns site environmental monitoring and utility trend program. Hosts monthly, responsible for sharing trend information with the site QualityCouncil, and identifies and escalates adverse trends appropriately. Drivescorrective/preventative actions, ensuring work is complete and the site remains in astate of control. Leads and coaches' others to perform environmental excursion investigations.Ensures corrective actions identified for the investigation are implemented in a timelymanner and monitored as part of the monthly trending meetings.Writes, reviews, and/or approves SOPs, sampling plans, and protocols. Develops and maintains a tool for monitoring QC resource capacity. Providesfeedback to QC management, program management, and production planners whencapacity constraints exist. Leads, mentors, and coaches staff through routine one-on-one meetings, teammeetings, and effective performance management. Sets and delivers on individual and team goals that support the department and site strategy. Takes personal accountability for both his/her own and the team’s actions. Represents the QC-Environmental Monitoring department during internal andexternal audits. Prepares monthly management reports including budget analysis and projectupdates. Actively monitors spending for area. Predicts and escalates potentialspending variances.Identifies corrective actions for spending variances. Performs other duties as assigned.Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. Reference: R71728



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