QC Environmental Monitoring Analyst III Lead

Essential Duties and Responsibilities

• Performs routine Environmental Monitoring of the classified clean rooms.
• Performs routine utility sampling and analysis of Water for Injection Systems, RO/DI, USP Purified water systems, and Clean Steam systems.
• Monitors classified clean rooms during manufacturing operations; must be gown qualified.
• Performs routine monitoring and analysis of the Clean Compressed Air System.
• Writes and executes protocols, experiments, and notebook studies.
• Authors and collaborates on SOP creation and updates.
• Reviews work of peers for GDP and ALCOA+.
• Performs data review of paper and electronic records.
• Handles preparation of investigations, reports and execution of complex protocols.
• Conducts visual inspection of media fill vials and plates.
• Assists with scheduling routine work and support coverage.
• Performs general lab maintenance/housekeeping.
• Trains staff in routine and advanced processes.
• Attends and contributes to cross-functional meetings as needed.

Special 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 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.
• Able to work in a highly complex environment with competing demands and priorities.

Qualifications

• 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.
• Highly detail-oriented.
• Easily adaptable to changing priorities and deadlines.
• Exceptional organizational skills.
• Professional verbal communication skills required.
• Excellent computer skills; the ability to learn new software.
• Ability to work varied hours as required by the production schedule.
• Working/theoretical knowledge of lab equipment.
• Ability to identify and execute process improvements.
• Ability to gown to work in an ISO-8 through ISO-5 environment.