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.

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 health needs of the community, and move our collective knowledge forward. If you’d like to add enriching human life to your profile, UChicago Medicine is for you. Here at the forefront, we’re doing work that really matters. Join us. Bring your passion.
UChicago Medicine is growing; discover how you can be a part of this pursuit of excellence at: UChicago Medicine Career Opportunities.
UChicago Medicine is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, ethnicity, ancestry, sex, sexual orientation, gender identity, marital status, civil union status, parental status, religion, national origin, age, disability, veteran status and other legally protected characteristics.
Must comply with UChicago Medicine’s COVID-19 Vaccination requirement as a condition of employment. If you have already received the vaccination, you must provide proof as part of the pre-employment process. This is in addition to your compliance with the Flu Vaccination requirement as well. Medical and religious exemptions will be considered consistent with applicable law. Lastly, a pre-employment physical, drug screening, and background check are also required for all employees prior to hire.

Please refer the Job description for details