Quality Control Specialist

Job Title: Environmental Monitoring SpecialistScheduleMondayFriday, 8:30 AM 5:00 PMOccasional weekend or holiday work (rare)Position SummaryThis role is responsible for overseeing the Environmental Monitoring (EM) Program within an Advanced Cellular Therapeutics Facility. The individual will design, implement, and maintain a sustainable monitoring program to ensure compliance with quality and regulatory standards.The position requires collaboration with internal stakeholders and external vendors, along with independent decision-making to identify risks and improve processes.Key ResponsibilitiesProgram Development & Implementation Establish and implement the facilitys environmental monitoring programCollaborate with third-party vendors to define best practicesDevelop processes and schedules for ongoing monitoring activitiesData Analysis & Reporting Conduct environmental monitoring testingReview, analyze, and trend environmental dataProvide regular reports on environmental status and emerging trendsQuality & Compliance Ensure adherence to Good Manufacturing Practices (GMP)Investigate environmental excursions and contamination eventsIdentify root causes and implement corrective actionsDocumentation & Training Create and maintain technical documentation for the EM programTrain technicians on: Aseptic techniquesGowning procedures and qualificationsContinuous Improvement Work independently to identify risks and improve monitoring processesDevelop and implement corrective and preventive actions (CAPA)Required Qualifications Bachelors degree (required)Knowledge of Microsoft Office (Word, Excel, PowerPoint)Understanding of Good Manufacturing Practices (GMP)Preferred Qualifications Minimum 3 years of experience in a GMP environmentExperience in environmental monitoring within manufacturing or laboratory settings