The QC Microbiologist III/Team Lead position 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. With general supervision, the microbiologist team lead 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, addresses non routine matters. Utilizes technical knowledge and experience to resolve complex problems. Escalates matters requiring resolution by management. Works with, reviews and revises records and standard operating procedures. Trains and guides less experienced personnel. Is a model of the Guardian values and behaviors. Effectively communicates any issues with upper management to reach business goals effectively.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• 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 test 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

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• Exceptional organizational skills, detail oriented

• Strong ability to plan and prioritize complex activities to meet goals and objectives
• Strong analytical skills to identify risks and prepare balanced decisions
• Ability to gown to work in an ISO-5 environment
• Ability to work varied hours as required by the production schedule
• Professional verbal communication skills required
• People management skills
• Solid computer skills
• Working/theoretical knowledge of lab equipment
• Ability to identify process improvements

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear
• Ability to sit or stand for prolonged periods of time
• Must be able to walk and drive between locations
• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves
• Must be able to occasionally lift and/or move up to 50 pounds
• Must pass eye exam
• Comfortable with working/handling of hazardous materials

• Follow written instructions. Perform independent troubleshooting of common issues. Provide expertise for response to complex issues.
• Able to work in a highly complex environment with competing demands and priorities

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• High school Diploma, GED, or equivalent credential required; 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.

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