Quality Control Supervisor, Environmental Monitoring and Microbiology
United States, Houston (Texas)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
The purpose of this role is to lead, perform, and coordinate the Quality Control, Environmental Monitoring team in maintaining the cleanrooms for commercial manufacture for both At Rest and In Operation conditions. This role will also coordinate environmental monitoring performance qualifications for new clean room and will be central in all assays associated with microbiology and integral with microbial investigations, excursion report writing, and general upkeep of the micro department.
- Coordination of environmental monitoring and performance where required. Level 3 gowning qualification is required. There will be events where many hours within the cleanroom at level 3 gowning is required. Work hours may vary dependent on the demands of individual manufacture events.
- Coordination of environmental monitoring performance qualifications (EMPQ) for new cleanrooms.
- Maintenance of and coordination of calibrations for environmental monitoring equipment.
- Prepare/ establish standard operating procedures, write and coordinate excursion reports and environmental investigations, and write/ review trend reports.
- Ensure corporate, Good Manufacturing Practice (cGMP), and regulatory guidance of all activities within the department. Perform review of data collection and assay documents.
- Represent Quality Control, as needed, in audits and associated client exchanges. Provide communication and coordinate schedules/ efforts with other departments to support manufacture operations.
- Leads, mentors, and coaches staff through routine one-on-one meetings, team meetings, and effective performance management. Sets and delivers on individual and team goals that support the group and site strategy. Takes accountability for both his/ her own and the team’s actions.
- Monitor and approve timesheets and other administrative duties for personnel.
- Scheduling of analyst work
- Bachelor Degree in Life Sciences, preferably in Microbiology/Biology.
- Demonstrated knowledge in and microbiological assays, environmental monitoring, associated regulatory guidelines, and aseptic processing. Should possess knowledge of how to execute test methods/procedures and operate equipment. May need to support and/or execute analyst tasks on a non-routine basis.
- Develops training plans and performs identification and remediation of training gaps.
- Advanced knowledge of Good Manufacturing Processes (cGMP).
- Knowledge of SAP, MODA, and TrackWise systems a plus.
- Able to identify and respond to complex problems, interpret complex data and draw valid conclusions.
- Communicates thoughts, ideas, information, and messages which may contain technical information in a logical, organized, and coherent manner
- Motivates team to be flexible and to respond to planned and unplanned or unanticipated changes with speed and confidence.
- Champions change speaking positively to and about others in all situations. Encourages a positive, solutions-focus attitude in all team members.
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.