What are the responsibilities and job description for the QC Micro Analyst position at Confidential Careers?
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. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.
This position will report to the Supervisor of QC Microbiology. The Quality Control Microbiology Analyst II serves as a support role to clinical and/or commercial production. 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
- 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 with 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
- Minimum 2-4 years of experience with environmental monitoring or within the biopharmaceutical industry
- Proficient with computer software such as Microsoft Office, MODA, LIMS
- Familiar with ISO and EU standards
- Strong written and oral communication 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
- Employment as a QC Microbiology Analyst II is contingent on the ability to obtain a qualified gowning status within 90 days of start date.
