Quality Supervisor, Advanced Cellular Therapeutics Lab - Full-Time, Day Shift

University of Chicago•Chicago, IL

4d•Onsite

About The Position

Be a part of a world-class academic healthcare system, UChicago Medicine, as a Quality Supervisor in the Advanced Cellular Therapeutics Facility/Clinical Cell Processing Laboratory. Here, you will function as a hospital staff member who, under the direction of an assistant director and lab director, maintains oversight of the Quality and Compliance Program of the ACTF. The Quality Supervisor will generate Quality Dashboard Indicators and trending including data analysis. Leads calibrations and verifications on quality systems (for the latter, perform as well as assign to other laboratory technologists). The quality systems include, but are not limited to, quality audits, equipment and process validations, and change control. This position is a 100% onsite opportunity. You will need to be based in the greater Chicagoland area. The Quality Supervisor leads, performs, and assigns deviation investigations, including conducting root cause analysis and implementing CAPAs and assessing their effectiveness at remediating the root cause. Responsible for implementing corrective actions to address findings identified by external audits, reviews and/or authors SOPs, worksheets, forms, and upholds the document control system, and shares responsibility for reviewing equipment Quality control and cleaning logs. The Quality Supervisor acts as the liaison for ACTF with the Transplant & Cellular Therapy (TCT) Program quality and regulatory specialist. Responsible for supervising QA/QC functions of technologists.

Requirements

BA or BS, required.
Adaptability to multiple, changing demands is essential and requires exceptional organizational skills and ability to work under potential stressful scenarios.
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.

Nice To Haves

3-5yrs prior clinical experience related to cellular therapy preferred.
Proficiency and familiarity with quality assurance and quality control in the field of cellular therapy related to Good Tissue Practices (GTP) and current Good Manufacturing Practices (cGMP) is highly preferred.

Responsibilities

Provides supervisory oversight of the Quality and Compliance Program of the ACTF, including supervision of the QA and Lead Laboratory Quality & Compliance Technologist in the performance of the following functions:
Investigates deviations, including conducting root cause analysis and implementing CAPAS and assessing their effectiveness at remediating the root cause.
Reviews and/or authors SOPs, worksheets, forms, and upholds the document control system.
Shares responsibility for reviewing equipment Quality control and cleaning logs.
Upholds laboratory compliance with all Good Laboratory Practices requirements and standards for procedures as they are established for stem cell transplant.
Responsible for being the liaison for the clinical lab with the program QA manager.
Responsible for training new employees on quality related functions.
Responsible for generating Quality Dashboard Indicators and trending including data analysis.
Assist in IND preparation pertaining to quality/release of cellular therapy product.
Responsible for leading Calibrations and verifications on quality systems (perform as well as assign to other techs).
Implementing corrective actions to address findings identified by external audits.