Quality Control Supervisor - Environmental Monitoring

Lonza•Houston, TX

3d•Onsite

About The Position

The Quality Control Supervisor – Environmental Monitoring will lead and coordinate Environmental Monitoring (EM) activities to ensure the site maintains a compliant state of control and supports world-class manufacturing operations. This role is responsible for supervising Environmental Monitoring personnel, overseeing cleanroom monitoring programs, driving investigations and corrective actions, ensuring compliance with cGMP requirements, and supporting internal and external audits. The position serves as a key leader within Quality Control, partnering with cross-functional teams to maintain environmental compliance, support operational readiness, and deliver continuous improvement initiatives.

Requirements

Experience in Quality Control within a cGMP-regulated environment.
Bachelor’s degree in a scientific discipline, preferably Microbiology.
Experience with cleanroom operations and Environmental Monitoring programs.
Level 1 and Level 2 gowning experience required.
Strong knowledge of microbiological testing, microorganism identification, environmental monitoring, and aseptic processing.
Demonstrated ability to schedule work effectively and coordinate team resources.
Proficiency with spreadsheets, databases, and word processing applications.
Strong problem-solving, decision-making, and investigative skills.
Excellent communication and interpersonal skills, with the ability to provide feedback, build relationships, and influence outcomes across functions.
Ability to lead teams in a fast-paced manufacturing environment while maintaining high standards of quality and compliance.
Ability to work the Saturday through Tuesday 4x10 schedule.

Nice To Haves

Previous leadership, supervisory, or team management experience preferred.
familiarity with systems such as SAP, MODA, and TrackWise is preferred.

Responsibilities

Lead and coordinate the Quality Control Environmental Monitoring team to maintain cleanroom environments in both At Rest and In Operation conditions.
Supervise Environmental Monitoring personnel, providing technical guidance, scheduling support, coaching, performance management, and professional development.
Coordinate and perform microbiological assays and environmental monitoring activities, including support of epidemiological investigations and excursion report generation.
Review testing records, laboratory documentation, and monitoring data to ensure compliance with cGMP requirements and site procedures.
Develop, maintain, and continuously improve Environmental Monitoring and utility monitoring programs, policies, sampling plans, and procedures.
Manage environmental and utility trend programs, analyze data, and facilitate routine trend reviews to proactively identify and address issues.
Lead environmental excursion investigations and drive timely implementation of corrective and preventive actions (CAPAs) to maintain site control.
Author, review, and approve SOPs, protocols, reports, and other Quality Control documentation.
Develop tools and metrics to monitor laboratory performance, resource capacity, efficiency, and quality objectives.
Collaborate with manufacturing, quality assurance, facilities, and other cross-functional teams to ensure effective environmental monitoring support for operations.
Represent the QC Environmental Monitoring department during customer audits, internal audits, and regulatory inspections.
Prepare responses to audit observations, deviations, investigations, and customer complaints.
Prepare project plans, management reports, presentations, and departmental communications.
Monitor departmental spending and provide monthly reporting on budget performance and operational metrics.
Support staffing activities, onboarding, workforce planning, and the continued development of a high-performing Environmental Monitoring team.
Perform other duties as assigned.