Lead Laboratory Quality & Compliance Technologist, Apheresis - Day Shift

Job Description

Be a part of a world-class academic healthcare system, UChicago Medicine, as a Lead Laboratory Quality & Compliance Technologist in the Advanced Cellular Therapeutics Facility.  Here, you will be responsible for collecting and analyzing data pertaining to cell processing, cryopreservation, infusion and patient engraftment as well as additional quality metrics with regards to facility equipment, environmental monitoring and staff training. The position also requires gaining knowledge and assisting the Facility Director and manager in formulating policies for compliance with 21 CFR part 1271 regulations. It is expected the person will generate routine quality reports including but not limited to deviation reports, release of manufactured cellular therapy products for patient infusion, investigates planned and unplanned deviation and take the lead role during external audits by regulatory authorities and Pharma companies that partner on clinical trials. It is expected the person will present quality reports at quarterly program quality meetings.  This department is the Advanced Cellular Therapy Department. This position is a 100% onsite opportunity. You will need to be based in the greater Chicagoland area.

 

Eligible for a Sign On Bonus up to $10,000

 

The Lab Quality Officer in the Clinical Cell Processing Laboratory (Cell Lab) functions as a hospital staff member who, under the direction of a lab manager and lab director, generates Quality Dashboard Indicators and trending including data analysis. Leads Calibrations and verifications on quality systems (perform as well as assign to other techs). Responsible for review on a monthly basis the Cell Lab equipment and environmental monitoring system graphs. Incumbent acts as the liaison for the clinical lab with the program QA manager. Responsible for the oversight of monthly QA/QC. Responsible for supervising QA/QC functions of technologists.

 

Essential Job Functions

 

• Responsible for generating Quality Dashboard Indicators and trending including data analysis
• Responsible for the oversight of monthly QA/QC
• Responsible for supervising QA/QC functions of technologists
• Responsible for being the liaison for the clinical lab with the program QA manager
• Responsible for review on a monthly basis the Cell Lab equipment and environmental monitoring system graphs
• Responsible for leading Calibrations and verifications on quality systems (perform as well as assign to other techs)
• Fulfills all Good Laboratory Practices requirements and standards for procedures as they are established for stem cell transplant
• Contacts appropriate ancillary departments for various requests as necessary (i.e. blood bank, hematology, environmental services, plant department, etc.)
• Communicates with oncoming shift any pertinent information
• Generates computer work sheets, lab inventory, reports, labels, tables, order forms, and updates/maintains computer database
• Assembles, organizes, and maintains patient files
• Schedules and documents quality assurance testing and repairs of equipment
• Performs other duties as assigned

Required Qualifications

 

• Bachelors Degree
• Ability to work in high volume, stressful situations
• Excellent communication and interpersonal skills to deal with multi-disciplinary team, patients, and outside collaborators
• Ability to act in a professional manner with individuals at all levels
• Ability to work independently and in team efforts
• Considerable skill in maintaining records and files

Preferred Qualifications

 

• 3-5 years of prior clinical experience related to cellular therapy
• Proficiency and familiarity with quality assurance and quality control in the field of cellular therapy
• High degree of computer literacy, knowledge and ability to use laboratory/hospitals information systems
• Familiarity with Sections 351 and 361 of the Public Health Service Act

 Position Details 

 

• Job Type/FTE: Full Time (1.0 FTE)
• Shift:  Day Shift (8:30 am - 5:00 pm), Monday-Friday
• Location: Hyde Park
• Unit/Department: Apheresis/Advanced Cellular Therapy Laboratory 
• CBA code: Non-Union

Why Join Us

We’ve been at the forefront of medicine since 1899. We provide superior healthcare with compassion, always mindful that each patient is a person, an individual. To accomplish this, we need employees with passion, talent and commitment… with patients and with each other. We’re in this together: working to advance medical innovation, serve the hea