Jobs · Quality Assurance · Texas

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.

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