Quality Control Microbiologist

Summary

• We are seeking a highly motivated individual to join us as a QC Microbiology Technician in our new commercial cell therapy production center located in Frederick, MD.
• You will work with the Quality Control team in supporting our efforts in this exciting new area of cancer immunotherapy.
• This position provides Quality Control microbiological testing for clinical and commercial manufactured product, responsible for product testing, microbial growth promotion testing, utility testing and environmental monitoring.

The QC Microbiology Technician performs essential laboratory support functions to ensure the integrity of microbiological testing and environmental monitoring programs within a GMP-regulated manufacturing environment.

Key responsibilities include:

• Maintain laboratory areas in a clean, organized, and sanitized condition in accordance with established procedures and safety requirements.
• Perform environmental monitoring and/or utility monitoring activities, including sampling of classified manufacturing areas, utilities, and support systems, as a primary job function.
• Receive, inspect, quarantine, and appropriately store purchased microbiological media and supplies pending laboratory approval and release.
• Monitor biohazardous waste accumulation and coordinate the safe removal and disposal of waste with qualified Environmental Health and Safety (EHS) personnel.
• Support validation, qualification, development, and commercial manufacturing activities through execution of assigned microbiological and laboratory support tasks.
• Maintain compliance with applicable GMP, safety, environmental, and company requirements while documenting activities accurately and contemporaneously.
• Collaborate effectively with Quality Control, Manufacturing, Quality Assurance, and other site functions to support operational objectives.
• Perform additional duties and special projects as assigned by management.
• Ensure assigned responsibilities may be appropriately delegated to qualified and trained deputies when operational needs require.

Basic Qualifications:

• AA Degree and 1 years’ experience in Microbiology lab/Environmental Monitoring OR
• HS Degree and 2 years’ experience in Microbiology lab/Environmental Monitoring OR
• Preferred Qualifications:
• Experience in the application of microbiological techniques such as environmental air monitoring, water testing, surface monitoring
• Experience in aseptic techniques and clean room operations
• Ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs.
• Ability to pass vision exam for visual inspection
• Knowledge of GMP, SOPs and quality control processes for commercial manufacturing
• Proficient in MS Word, Excel, Power Point and other applications
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• Ability to be flexible with schedule, and work overtime as needed