GxP Validation Engineer

The Quality Control Analyst II is responsible for maintaining high standards of laboratory operations and ensuring compliance with regulatory requirements. Key responsibilities include: -Performs microbiological validations for raw materials and finished products, including Bioburden, Endotoxin, Sterility, and PET. -Provides support to QC Microbiology laboratories. -Conducts equipment qualifications. -Organizes and assists with Media Fill and Reads. -Identifies ongoing quality issues, prevents potential problems, and suggests improvements. -Interprets and evaluates analyses for accuracy and precision against established specifications, recommending and implementing corrective actions when necessary. -May be responsible for analytical and protocol report writing, as well as standard operating procedures. -Strictly adheres to Good Documentation Practices (GDP). -Collaborates with and supports coworkers to enhance the organization's overall capabilities. -Communicates effectively with production, maintenance, warehouse, and other relevant functions. -Participates in problem-solving and troubleshooting. -Supports training needs of team members and works cohesively with the team. -Coordinates with and supports other departments to ensure smooth workflow execution. -Ensures the availability of supplies and equipment to meet schedules and carries out tasks as defined by the schedule. Pay: $55.00 - $60.00 per hour Expected hours: 40.0 per week Work Location: In person