Technician, Quality Control Environmental Monitoring
About The Position
The QC Environmental Monitoring Technician is a crucial role in maintaining the integrity and safety of our cell therapy products, conducting routine and non-routine testing to ensure the environmental conditions in our cell therapy manufacturing facility meet the highest quality standards. The incumbent performs testing according to established operating procedures. Conducts routine environmental monitoring activities in the cell therapy manufacturing facility, including air and surface monitoring, to ensure compliance with regulatory requirements. Collects samples from critical areas within the manufacturing facility according to established procedures. Maintains and calibrates environmental monitoring equipment regularly to ensure accuracy and reliability of measurements. Maintains accurate and up-to-date records of environmental monitoring activities, including sampling plans, results, and corrective actions taken. Environmental analyses, including microbial and particulate matter testing. Performs basic lab functions like reagent preparation.
Requirements
- Prepare basic and complex reagents as assigned
- Order and maintain lab supply inventory
- Aliquot samples as required, including aseptic aliquoting
- Receive and provide training
- Participate in assay transfer and assay validation
- Perform equipment qualification/maintenance
- Identify and support resolution of technical problems
- Actively participate in group and project teamwork; project and process improvements
- Resolve issues as needed with management approval
- Adhere to cGMP policies and procedures, including documentation activities
- Perform other duties as requested by supervisor/manager to support Quality
- Willingness to work swing and night shifts
Responsibilities
- Perform a broad variety of basic and moderate complex tests in support of lab operations
- Perform testing of routine and non-routine samples and documents according to cGMP
- Perform routine lab and equipment maintenance
- Troubleshoot and address any equipment issues promptly to minimize downtime
- Prepare basic and complex reagents as assigned
- Order and maintain lab supply inventory
- Aliquot samples as required, including aseptic aliquoting
- Receive and provide training
- Perform other duties as requested by supervisor/manager to support Quality
- Collaborate with cross-functional teams, including manufacturing, quality control, and quality assurance, to address environmental monitoring-related issues and implement corrective actions
- Prepare basic and complex reagents as assigned
- Order and maintain lab supply inventory
- Aliquot samples as required, including aseptic aliquoting
- Receive and provide training
- Participate in assay transfer and assay validation
- Perform equipment qualification/maintenance
- Identify and support resolution of technical problems
- Actively participate in group and project teamwork; project and process improvements
- Resolve issues as needed with management approval
- Adhere to cGMP policies and procedures, including documentation activities
- Perform other duties as requested by supervisor/manager to support Quality
- Willingness to work swing and night shifts
Benefits
- competitive medical, dental, and vision benefits
- flexible PTO
- 401(k) plan
- life and accidental death and disability coverage
- parental leave benefits
- free daily lunches and snacks at our on-site locations
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
Number of Employees
251-500 employees
