Cincinnati Children's Office of Academic Affairs and Career Development ยท 2 weeks ago
Technician I/II-GXP - Applied Gene & Cell Therapy Center (Operations, Controls, and Support Group)
Cincinnati, OH
Full-time
Onsite
New Grad, Entry, Mid Level
$54K/yr - $67K/yr
0+ years expCincinnati Children's is a leading children's hospital focused on improving children's health through a holistic team approach. They are seeking a Technician I/II to oversee day-to-day operations, maintain laboratory equipment, and ensure compliance with regulatory standards in a GxP environment.
Hospital & Health Care
Responsibilities
Oversee and perform day-to-day operations including cleanroom facilities maintenance, project management, and fee-for-service support as assigned
Troubleshoot and correct erroneous results or problems with laboratory equipment
Maintain, repair, calibrate, and/or validate equipment as needed
Monitor proper equipment use by all personnel
Maintain inventory of laboratory supplies and equipment; order supplies from vendors and storeroom and ensure proper storage requirements are met
Maintain stocks of chemicals and solutions
Report equipment and/or facility related system failures or alarms to laboratory management or QA team
Perform day-to-day operations including cleanroom facilities maintenance and equipment maintenance plus fee-for-service support as assigned
Operate standard laboratory equipment according to protocol
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
Maintain stocks of chemicals and solutions
Report facility and equipment failure and alarms to laboratory management or QA team
Perform maintenance and cleaning of the cleanroom manufacturing facility
Routinely perform the Environmental Monitoring sampling and/or testing of the sampled media
Support equipment and facility calibration and validation activities
Request and schedule services with vendors related to lab, cleanroom, and equipment operations
Complete accurate and detailed records
Complete and maintain training required to perform assigned tasks
Perform work with a high level of integrity and honesty
Practice a high level of integrity in maintaining confidentiality
Maintain required documentation systems
Provide Material Safety Data Sheet (MSDS) training according to regulations
Communicate with external vendors to obtain technical information as needed
Assist in daily operations of the laboratory including answering phone, maintaining lab supplies, organization, and cleanliness
Provide written and oral reports to management on a regular basis
Provide appropriate safety monitoring checks as assigned (radiation safety, biosafety, etc.)
Perform other duties as assigned
Create, modify, and follow Standard Operating Procedures (SOPs) and Validation Protocols
Cooperate with performance improvement initiatives and other compliance activities
Interact with QA to coordinate manufacturing, processing, and testing activities (i.e. production suite cleaning schedule, release of the production suite, issuance of batch record, completion of equipment validations, etc.)
Cooperate with Quality Assurance group to ensure the quality of product, test results and compliance
Perform assigned duties strictly according to SOP
Maintain optimal protocol and assay accuracy by conducting regular quality and reproducibility checks
Maintain required proficiency and competency requirements
Analyze data, perform statistical and graphical analysis of data, and interpret results
Perform qualification and validation activities for equipment/instrumentation, facilities, laboratory methodology and quality assurance procedures that are essential to the GxP operations
Maintain an active role in the department meetings, presentations, and publications
Train laboratory personnel on proper GxP and regulatory compliance techniques
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
Qualification
Required
High school diploma or equivalent
3 - 5 years of work experience in a related job discipline or equivalent combination of education and experience
Bachelor's degree in a related field
0 - 2 years of work experience in a related job discipline
Preferred
Experience in a regulated environment (i.e. FDA, ISO, CAP, CLIA, FACT)
cGMP experience
Cleanroom Operations
Benefits
Medical coverage starting day one of employment. View employee benefits here.
Competitive retirement plans
Tuition reimbursement for continuing education
Expansive employee discount programs through our many community partners
Shift Differential, Weekend Differential, and Weekend Option Pay Programs for qualified positions
Support through Employee Resource Groups such as African American Professionals Advisory Council, Asian Cultural and Professional Group, EQUAL - LGBTQA Resource Group, Juntos - Hispanic/Latin Resource Group, Veterans and Military Family Advocacy Network, and Young Professionals (YP) Resource Group
Physical and mental health wellness programs
Relocation assistance available for qualified positions
Benefits may vary based on FTE Status and Position Type
Company
Cincinnati Children's Office of Academic Affairs and Career Development
This is the official LinkedIn group for the Cincinnati Childrens Office of Academic Affairs and Career Development.
Cincinnati, Ohio, US
5001-10000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase