Lead Laboratory Quality & Compliance Technologist, Advanced Cellular Therapeutics Laboratory - Full-Time, Day Shift

UChicago Medicine; Illinois; On-site; USD 90,000 - 130,000; Full time

Job summary

UChicago Medicine Duchossois Center for Advanced Medicine in Chicago’s Hyde Park invites applications for a Lead Quality & Compliance Technologist in the Advanced Cellular Therapeutics Laboratory. You will oversee QA/QC for technologists, generate quality dashboards, and liaise with the program QA manager to ensure compliance with GLP for stem cell procedures.

Based in the greater Chicagoland area, this 100% on-site role emphasizes collaboration with RN/PA/physician teams and meticulous data

Qualifications

• BA or BS, required.
• Availability to work some evenings, weekends, and holidays 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
• Knowledge and ability to use automated and conventional laboratory equipment
• Considerable skill in maintaining records and files
• Possess good analytical capabilities

Responsibilities

• Supervise QA/QC functions of technologists
• Oversee monthly QA/QC activities
• Generate Quality Dashboard indicators and trending including data analysis
• Liaise for the clinical lab with the program QA manager
• Review monthly the Cell Lab equipment and environmental monitoring system graphs
• Lead calibrations and verifications on quality systems
• Process, manipulates and cryopreserves specimens
• Reinfuse specimens at patient bedside with RN/PA/physician
• Ensure GLP requirements for stem cell transplant procedures
• Maintain sterile or aseptic technique as required
• Learn and adopt new procedures and upgrades
• Coordinate with ancillary departments as needed
• Display initiative and adapt to procedural changes
• Communicate updates to oncoming shift
• Update and maintain computer databases
• Label blood product containers
• Maintain location records for all specimens
• Ensure requisite paperwork is complete for harvest/reinfusion
• Prepare reports and inventory worksheets
• Complete daily temperature logs and QC logs
• Monitor storage facilities (LN2, CO2, refrigerators, incubators)
• Schedule QA testing and equipment repairs
• Move and connect tanks
• Select data from databases for analysis
• Update patient storage status reports

Skills

QA/QC supervision

Data analysis

Communication

Team collaboration

Education

BA or BS

Tools

LIMS

Automated lab equipment

Job description

Job Description

Be a part of a world-class academic healthcare system,

Job Description

Be a part of a world-class academic healthcare system, UChicago Medicine, as a Lead Quality & Compliance Technologist in the Advanced Cellular Therapeutics Laboratory. Here, you will collect, evaluate, process, preserve, and re-infuse unique cells that are vital to patient recovery and survival. The Lead QC Technologist will generate Quality Dashboard indicators and trends (including data analysis) and is responsible for reviews of the Cell Lab equipment and environmental monitoring system graphs. Leads calibrations and verifications on quality systems (perform as well as assign to other techs). Incumbent acts as the liaison for the clinical lab with the program QA manager and is responsible for supervising QA/QC functions of technologists. This position is a 100% onsite opportunity. You will need to be based in the greater Chicagoland area.

Essential Job Functions

• Responsible for supervising QA/QC functions of technologists


• Responsible for the oversight of monthly QA/QC


• Responsible for generating Quality Dashboard Indicators and trending including data analysis


• 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)


• Processes, manipulates and cryopreserves specimens


• Working in tandem with an RN, PA, or physician, reinfuses specimen at patient's bedside


• Fulfills all Good Laboratory Practices requirements and standards for procedures as they are established for stem cell transplant


• Practices sterile or aseptic technique as deemed necessary


• Learns new procedures and adopts different techniques as required by upgrades and fine-tuning of our treatment modalities


• Contacts appropriate ancillary departments for various requests as necessary (i.e. blood bank, hematology, environmental services, plant department, etc.)


• Exhibits appropriate initiative as needed, i.e., reading and understanding all protocols, adapting to changes in procedures or environment, etc.


• Communicates with oncoming shift any pertinent information


• Updates and maintains computer database


• Labels all blood product containers such as bags, vials, vial boxes, etc.


• Records, maintains, and is accountable for location of all specimens in storage


• Ascertains all requisite paperwork is complete prior to hematopoietic stem cell harvest and re/infusion


• Generates computer work sheets, lab inventory, reports, labels, tables, and order forms


• Assembles, organizes, and maintains patient files


• Fills out and obtains necessary signatures for all forms as required according to procedure


• Prepares and processes other documents as deemed necessary by supervisor


• Completes daily temperature logs and other quality control logs


• Monitors proper functioning of storage facilities, including levels of liquid nitrogen and carbon dioxide used in operating refrigerators and incubators


• Schedules and documents quality assurance testing and repairs of equipment


• Moves and connects tanks


• Selects data from database and conducts data analysis


• Updates status reports of patients for whom cells are in storage

Required Qualifications

• BA or BS, required.


• Availability to work some evenings, weekends, and holidays 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


• Knowledge and ability to use automated and conventional laboratory equipment


• Considerable skill in maintaining records and files


• Possess good analytical capabilities

Preferred Qualifications

• Certification or certified eligible as a Medical Technologist through American Society of Clinical Pathologists (ASCP); or a minimum of 3 years of experience in clinical cell processing in lieu of certification is preferred


• 3-5rs prior clinical experience related to cellular therapy preferred


• Proficiency and familiarity with quality assurance and quality control in the field of cellular therapy is highly preferred


• High degree of computer literacy, knowledge and ability to use laboratory/hospitals information systems is preferred

Duchossois Center for Advanced Medicine (DCAM) - Hyde Park

5758 S Maryland Ave

UChicago Medicine Duchossois Center for Advanced Medicine - Hyde Park, also known as DCAM, is located in Chicago's historic Hyde Park neighborhood, this six-story building puts comprehensive diagnostic care and world-class treatment under one roof.

Home to dozens of primary and specialty clinics as well as a pharmacy, the building includes more than 300 exam rooms, nearly 100 procedure rooms, surgery suites and imaging equipment including PET/CT and MRI scanners. It also has facilities for nuclear medicine along with linear accelerators and simulators for radiation therapy.

UChicago Medicine’s team of world-class clinicians diagnose and treat your illness and injury in additional to delivering expert specialty care for some of the most complex conditions. This academic-powered, integrated approach has recently been adopted across specialty areas that include digestive diseases, heart and vascular, neurology, oncology (Cancer) orthopaedics, otolaryngology (ENT), women’s health and more.

DCAM brings the knowledge and resources of UChicago Medicine to the outpatient setting, including clinical trials in virtually every medical area and more research funded by the National Institutes of Health than anyplace else in Illinois.

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.