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.