Quality Control Supervisor - Environmental Monitoring
Lonza · Houston, TX · 4 wk ago
Quality AssuranceFull-time
About the role
This is an on-site position located in Pearland, TX, with a schedule of Saturday through Tuesday, 8:00 am to 6:30 pm (4x10 schedule). 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.
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.
Requirements
- Experience in Quality Control within a cGMP-regulated environment.
- Bachelor’s degree in a scientific discipline, preferably Microbiology.
- Previous leadership, supervisory, or team management experience preferred.
- 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; familiarity with systems such as SAP, MODA, and TrackWise is preferred.
- 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.
Benefits
- Performance-related bonus.
- Medical, dental and vision insurance.
- 401(k) matching plan.
- Life insurance, as well as short-term and long-term disability insurance.
- Employee assistance programs.
- Paid time off (PTO).
- Weekend differential.