Manager, QC Microbiology Environmental Monitoring

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.

Manages the QC Microbiology team which is responsible for environmental monitoring (routine and production), utility monitoring, and with the knowledge of microbiology testing such as bioburden, endotoxin, gram stain, and growth performance qualification. 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.

Key responsibilities:

Responsible for supervision of the EM 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 programs and policies. Ensures sampling plans are up to date and executed as planned.
Owns site environmental monitoring and utility trend program. Hosts monthly trending meetings, responsible for sharing trend information with the site Quality Council and identifies and escalates adverse trends appropriately. Drives corrective/preventative actions, ensuring work is complete and the site remains in a state of control.
Leads environmental excursion investigations. Ensures corrective actions identified for the investigation are implemented in a timely manner 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. Provides feedback to QC management, program management, and production planners when capacity constraints exist.
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 department and site strategy. Takes personal accountability for both his/her own and the team's actions.
Prepares responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA).
Prepares project plans, writes status reports, and gives oral presentations to customers and management.
Prepares monthly management reports including budget analysis and project updates. Actively monitors spending for area. Predicts and escalates potential spending variances. Identifies corrective actions for spending variances.
Develops and monitors team performance measures to understand effectiveness, efficiency, and quality of group performance.
Performs other duties as assigned.

Key requirements:

Expertise in aseptic processing, environmental monitoring, cleanroom qualification, and microbiological testing.
Data Analysis & Investigations: Skilled in trending environmental/utility data and leading contamination/excursion investigations.
Training & Gap Remediation: Proficient in developing training plans and addressing training gaps to ensure compliance.

Software Proficiency: Proficient in spreadsheets, databases, and word processing.
ERP & Quality Systems: Familiarity with SAP and TrackWise is a plus. Decision Making

Utilizes technical expertise to resolve complex issues and make sound decisions for departmental success.
Analyzes data to provide actionable insights, optimizing team efficiency. Planning & Prioritization

Project Management: Skilled in managing tasks and projects, setting clear goals, and tracking performance.
Aligns work with site and customer priorities, ensuring on-time completion.

Effective Communication: Communicates complex information clearly to various audiences, including non-technical stakeholders.
Conflict Resolution: Experienced in resolving conflicts and delivering constructive feedback.

Builds strong relationships within and across departments.
Leadership: Leads teams to meet objectives, fosters trust, and drives success through adaptability and mentorship.

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.

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Manager, QC Microbiology Environmental Monitoring