Job Description

QC Microbiology Analyst II – Allendale, NJ

Our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine.

This position will report into the Manager of QC Microbiology. The Quality Control Microbiology Analyst serves as a support role to clinical and commercial production at the Allendale, NJ facility. The QC Microbiology Analyst will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring.

• Essential Functions and Responsibilities Environmental monitoring in controlled environments:
• Non-viable particulate monitoring
• Active viable air monitoring Personnel monitoring
• Surface sampling
• Passive air monitoring
• Equipment monitoring:
• Ensure equipment is in proper working conditions
• Ensure all equipment is properly maintained/calibrated
• Program equipment with proper workflows
• Assist with routine laboratory testing
• Plate reads and incubations
• Shipping of test samples and equipment to contract laboratories for testing
• Produce documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Writing/conducting investigations pertaining to environmental monitoring and testing
• Develop and train QC Microbiology Analyst I personnel on relevant business processes
• Qualifications BA/BS in a science or relevant field required or equivalent experience
• Minimum 2-4 years of experience with environmental monitoring or within the biopharmaceutical industry.
• Proficient with computer software such as
• Microsoft Office
• MODA/LIMS
• Familiarity with ISO and EU standards
• Technical writing skills
• Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities

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