GXP Technician I - Applied Gene & Cell Therapy Center (Operations, Controls & Support)
About The Position
The GXP Technician I - Applied Gene & Cell Therapy Center (Operations, Controls & Support) role is responsible for completing accurate and detailed records and all documentation required for compliance to GxP. This role involves performing maintenance and cleaning of the cleanroom manufacturing facility, routinely performing Environmental Monitoring sampling and/or testing of sampled media, and supporting equipment calibration and validation. The technician will also be responsible for ordering supplies, reporting facility and equipment failures, and performing work with a high level of integrity and honesty. Additionally, the role includes following Standard Operating Procedures (SOPs), cooperating with performance improvement initiatives, and potentially assisting in training laboratory personnel and acting as a mentor to junior staff. The scope of work includes raw materials, EM, shipping, equipment maintenance, and basic manufacturing tasks.
Requirements
- High school diploma or equivalent
- 3+ years of work experience in a related job discipline or equivalent combination of education and experience
Responsibilities
- Complete accurate and detailed records and all documentation as required for compliance to GxP.
- Complete and maintain training required to perform assigned tasks.
- Analyze data, perform statistical and graphical analysis of data, and interpret results.
- Maintain an active role in laboratory's meetings.
- Perform maintenance and cleaning of the cleanroom manufacturing facility.
- Routinely perform the Environmental Monitoring sampling and/or testing of the sampled media.
- Support equipment calibration and validation.
- Promptly respond to and troubleshoot erroneous results or problems with laboratory equipment or facilities.
- Order supplies from vendors and storeroom and ensure proper storage requirements are met.
- Report facility and equipment failure and alarms to laboratory management or QA team.
- Perform work with a high level of integrity and honesty.
- Practice a high level of integrity in maintaining confidentiality.
- Maintain required documentation systems.
- Willing and able to assist in daily operations of the laboratory including answering phone, organizing and cleaning of laboratory.
- Provides appropriate safety monitoring checks as assigned (radiation safety, biosafety, etc.).
- Perform other duties as assigned.
- Follow Standard Operating Procedures (SOP) and protocols.
- Cooperate with performance improvement initiatives and other compliance activities.
- Cooperate with Quality Assurance group to ensure the quality of product, test results and compliance.
- Perform assigned duties strictly according to SOP.
- Maintain required proficiency and competency requirements.
- Assist in training laboratory personnel.
- May act as a mentor to more junior staff.
- Serve as the contact for resolution of complex issues, provide education, guidance and work direction.
- May provide input and feedback to managers on hiring decisions, professional development and performance management.
- Raw Materials, EM, Shipping, Equipment maintenance and basic manufacturing tasks.
Benefits
- Additional pay (e.g., shift, on‑call, or weekend differentials) and benefits may apply.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
