Qc Microbiologist III/Lead, Sunday to Wednesday, 6:30 AM - 5 PM

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JOB SUMMARY

The microbiologist 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 LSNE.  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.

JOB DUTIES

• Maintains and adheres to safe work habits and all applicable LSNE 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

PROFESSIONAL SKILLS

• 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
• People management skills
• Professional verbal communication skills required
• Solid computer skills
• Working/theoretical knowledge of lab equipment
• Ability to identify process improvements

EXPERIENCE

• 3-4 years’ experience in a cGMP environment. 
• Two years of experience may be replaced by Associates/Non- Scientific Bachelor’s degree.  
• Three years of experience may be replaced with BS/BA degree in Microbiology or related scientific field.

EDUCATION

• High School Diploma required. BS/BA degree in Microbiology or related scientific field preferred.
• 2+ years of cGMP Pharmaceutical experience

PHYSICAL REQUIREMENTS & MENTAL DEMANDS

• 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

COMMUNICATIONS & CONTACTS

• Interacts with staff across QA, Operations, Facilities, and Validation to coordinate activities
• Interacts with QC management

MANAGERIAL & SUPERVISORY RESPONSIBILITIES  

• Leads team of technicians to complete scheduled