Supervisor, Quality Control - Environmental Monitoring

United States, Houston (Texas)

Today, Lonza is a global leader in life sciences operating across three 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.

The purpose of the QC Supervisor, Environmental Monitoring 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 be central in all assays associated with microbiology and integral with epidemiological investigations, excursion report writing, and general upkeep of the micro department.

Key responsibilities:

  • Performance and coordination of environmental monitoring.
  • Work hours may vary dependent on the demands of individual manufacture events.
  • Prepare/ establish standard operating procedures, write and coordinate excursion reports and environmental investigations, and write/ review trend reports.
  • Ensure corporate, cGMP, and regulatory guidance of all activities within the department. Perform review of data collection and assay documents.
  • Represent QC, 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.
  • Monitor and approve timesheets and other administrative duties for personnel

Key requirements:

  • Bachelors degree in scientific discipline, Microbiology preferred.
  • Advanced years of experience in Quality Control.
  • Adherence to cGMPs is required at all times during the manufacture of APIs
  • Level 3 gowning qualification is required.
  • Demonstrated knowledge in and microbiological assays, microorganism identification techniques, environmental monitoring, associated regulator guidelines, and aseptic processing. Should possess knowledge of how to execute team 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. 
  • Proficient in the use of spreadsheets, databases, and word processing software.
  • Knowledge of SAP, MODA, and TrackWise systems a plus.
  • Uses experience and knowledge to solve problems, make decisions or make plans for their area.  Makes recommendations for department. Erroneous decisions or failure to achieve results may cause delays in schedules.
  • Able to identify and respond to complex problems, interpret complex data and draw valid conclusions.
  • Improves efficiency of self and team by clearly defining and analyzing problems and implementing new ways of approaching work.
  • Demonstrated experience in management of complex tasks and projects
  • Able to plan activities for self, team, and group projects on an on-going basis.  Works with manager to ensure group timelines are aligned with department  goals.
  • Prioritizes work of team based on input from management and is able to clearly communicates rationale for priorities.
  • Can clearly and confidently communicate expectations effectively to all members of their team.
  • Uses mediation skills to avoid or resolve conflict.  Is able to deliver criticism in a constructive manner.
  • In conjunction with program management team, helps develop loyalty and trust with customers.  Able to make and deliver on promises of projects within group control.

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: R45699