QC Microbiologist III/Lead Sun - Wed 6AM - 4:30 PM

About the role

The QC Microbiologist III/Team Lead position at PCI leads others in a variety of complex tasks under general guidance and in accordance with current GMP/ISO requirements and standards, and following all safety guidelines of PCI. This role oversees and performs, when applicable, all day-to-day operations including but not limited to sampling and testing of production environments, lab work, and/or facility clean utilities, as per approved procedures. Additionally, this position addresses non-routine matters.

Responsibilities

• Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines.
• Is proactive in identifying safety risks and alerts management to take corrective action.
• Oversees, performs and provides training for routine Environmental Monitoring of the classified clean rooms.
• Oversees, performs and provides training for sampling and testing the Water for Injection System, USP Purified Water systems and Clean Steam systems.
• Oversees, performs and provides training for laboratory work; plate reads and utility testing, growth promotion of media.
• Accountable for completing daily tasks and reporting issues to management.
• Mentors less experienced staff in the performance of daily job tasks.
• Completes training and ensures proper training within the team prior to task assignments.
• Identifies, escalates and documents events that deviate from normal operation; perform investigations as needed.
• Peer review of quality control data.
• Routinely performs SOP document changes/updates.
• Preparation of investigations, reports and execution of complex protocols.
• Visual inspection of media fill vials.
• Perform, schedule and oversee general lab maintenance/housekeeping.
• Other duties as assigned.

Qualifications

• A high school diploma, GED, or equivalent credential required.
• An AS degree or BS degree in Microbiology or related scientific field preferred.
• 7-9 years’ experience in a cGMP environment; equivalent combination of education and experience will be considered.