GXP Technician I - Applied Gene & Cell Therapy Center (Operations, Controls, and Support Group)
About The Position
GMP Technician - 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. · Operations - 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. Complete accurate and detailed records. Complete and maintain training required to perform assigned tasks. 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. · Compliance - 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. · Process Improvement - 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. · Training & Development - 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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
