Quality Control Microbiology Tech

Job Description

Job 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.

Duties and Responsibilities:

• 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.
• HS Degree and 2+ years’ experience in Microbiology lab/Environmental Monitoring.

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.