GXP Technician I - Applied Gene & Cell Therapy Center (Operations, Controls & Support)

Cincinnati Children's•City of Oneida, NY

10d•$23 - $29

About The Position

The GxP Technician I supports day-to-day operations that keep a regulated laboratory environment operating safely and efficiently. This is a laboratory operations and support role focused on raw material receipt and control, rather than research. The work includes raw material product control, shipping and receiving, inventory and material handling, cleanroom techniques and procedures, and general laboratory support. The role requires attention to detail and adherence to established procedures in a quality-driven environment.

Requirements

High school diploma or equivalent.
At least 3 years of work experience in a related job discipline, or an equivalent combination of education and experience.
Ability to follow established procedures and maintain detailed records.
Experience in a regulated industry or operational environment is identified as ideal in the posting.

Responsibilities

Complete accurate and detailed records and documentation required for GxP compliance, and maintain required documentation systems.
Complete and maintain training, proficiency, and competency requirements for assigned tasks.
Analyze data, perform statistical and graphical analyses, and interpret results.
Participate actively in laboratory meetings.
Maintain and clean the cleanroom manufacturing facility.
Perform environmental monitoring sampling and/or testing of 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 the storeroom, and ensure they are stored appropriately.
Report facility and equipment failures and alarms to laboratory management or the Quality Assurance team.
Support daily laboratory operations, including answering phones and organizing and cleaning the laboratory.
Perform assigned safety monitoring checks, such as radiation safety and biosafety checks.
Follow SOPs and protocols, perform duties strictly according to SOPs, and cooperate with performance-improvement initiatives and compliance activities.
Work with the Quality Assurance group to support product quality, test-result quality, and compliance.
Assist with training laboratory personnel and may mentor more junior staff.
Serve as a contact for resolution of complex issues and provide education, guidance, and work direction.
May provide managers with input and feedback on hiring decisions, professional development, and performance management.
Perform raw materials, environmental monitoring, shipping, equipment maintenance, and basic manufacturing tasks.
Perform other duties as assigned.