Quality Supervisor, Advanced Cellular Therapeutics Lab

Quality Supervisor, Advanced Cellular Therapeutics Lab

Chicago, IL, United States

Job Description

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.

Essential Job Functions

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.

Position Details

• Job Type/FTE: Full-Time/1.0 FTE
• Shift: Day Shift
• Unit/Department: Advanced Cellular Therapeutics – Hyde Park
• CBA code: Non-Union

About 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.

As a condition of employment, all employees are required to complete a pre-employment physical, background check, drug screening, and comply with the flu vaccination requirements prior to hire. Medical and religious exemptions will be considered for flu vaccination consistent with applicable law.

Compensation & Benefits Overview

UChicago Medicine is committed to transparency in compensation and benefits. The pay range provided reflects the anticipated wage or salary reasonably expected to be offered for the position.

The pay range is based on a full-time equivalent (1.0 FTE) and is reflective of current market data, reviewed on an annual basis. Compensation offered at the time of hire will vary based on candidate qualifications and experience and organizational considerations, such as internal equity. Pay ranges for employees subject to Collective Bargaining Agreements are negotiated by the medical center and their respective union.

Review the full complement of benefit options for eligible roles at Benefits - UChicago Medicine.