QC Microbiologist

The Microbiologist is responsible for in-process and release testing of injectable pharmaceutical finished products. The role includes final product microbiological testing, maintenance of controlled areas, environmental monitoring, analysis of results, raw material testing, growth promotion testing and performing microbiological identification. The Microbiologist I participates in the periodic review of procedures and supports validation studies as they pertain to microbiology. Our Pharmaceutical Diagnostics (PDx) business is a global leader in imaging agents, used to improve and enhance the images that radiologists use to diagnose and monitor disease.

We support healthcare professionals in the administration of neurology, cardiology and oncology procedures that are used to image three patients around the world, every second.

• Perform required bioburden, sterility and bacterial endotoxin testing on final products and raw materials utilizing specialized equipment
• Work aseptically in sterile manufacturing and testing ISO classified clean rooms
• Perform viable and non-viable environmental monitoring
• Operate non-viable particle counter/facility monitoring systems
• Monitor sterility and environmental media for microbiological growth and perform incoming growth promotion testing
• Participate in validation projects requiring microbiology support
• Perform required procedures to initiate isolate identification from environmental samples and sterility tests
• Perform computer data entry with programs such as Microsoft Excel and MODA
• Maintain accurate records of environmental data and finished product/raw material testing
• Perform sample collection and testing of the Reverse Osmosis system that feeds the production autoclaves; operate a Total Organic Carbon analyzer
• Prepare supplies for sterilization (autoclave) and depyrogenation (dry heat oven)
• Perform requalification testing for gown and aseptic qualified operators
• Evaluate documentation and GMPs as they relate to microbiological issues
• Contribute to process improvement through Lean, 5S and six sigma tools
• Understand maintenance and use of biological indicators
• Create/perform unscheduled work orders and preventative maintenance records for laboratory upkeep

• Knowledge and understanding of acceptance activity requirements for incoming, in-process, and final inspection requirements (as associated with job type/position) to ensure that product conforms to its specification and out of specification items are properly handled
• Knowledge and understanding of Shop Orders, Concessions, Calibration, Preventative Maintenance, Material Identification & Segregation, documentation configuration control practices; documentation & disposition of non-conforming material, Part 11 compliance and Good Documentation Practices requirements, as associated with this job type/position
• Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
• Complete all planned Quality & Compliance training within the defined deadlines
• Identify and report any quality or compliance concerns and take immediate corrective action as required

• Required
  
  Schedule:
  
  Monday - Friday, 6:00 AM - 2:30 PM
• Bachelor’s degree in Microbiology or related Science degree
• Ability to speak, understand, read and write in local language
• Proficiency with Microsoft Office Suite (including Access)
• Availability for early shifts, weekends, and holidays as needed
• Ability to distinguish color
• Knowledge of microbiological techniques (gram stain/microbial , aseptic, gowning, etc.)
• Abil…