Department
BSD DFI - cGMP
About the Department
The Duchossois Family Institute (DFI) at the University of Chicago is using cutting-edge technologies and developing facilities to accelerate research and introduce novel interventions that optimize microbiome-mediated host defenses, with the goal of enhancing health. By developing new knowledge about the interactions between the human body and the microbiome, the DFI is breaking new ground that will lead to therapies that increase resistance to a wide range of diseases .
Job Summary
The job performs routine laboratory data collection and analysis to support clinical research, and assists in specialty research involving animals, MRI technologies, histology, among others.
Responsibilities
Perform in-process QC tasks (CFU viability, USP 61/62, media production) for drug substances and drug products.
Operate and maintain laboratory equipment such as anaerobic chambers, Biological Safety Cabinets, spectrophotometers, and pH meters.
Document QC tasks clearly and accurately on controlled forms and electronic systems (LIMS).
Participate in environmental monitoring of the cGMP facility.
Assist in investigations related to deviations and out-of-specification (OOS) results.
Maintain laboratory supply inventory and preventive maintenance / calibration schedule.
Perform routine maintenance of lab equipment including setup, cleaning, and appropriate care.
Maintain the highest standards of laboratory workplace safety and product quality.
Meet all training requirements for applicable Standard Operating Procedures (SOPs).
Follow verbal and written instructions and procedures for processes and equipment.
Identify and report non-conforming events in a timely manner.
Comply with regulations set forth in SOPs.
Perform peer review of cGMP manufacturing activities.
Prepares quality and safety control measures for the laboratory, such as checks of equipment, temperature control, and documentation of quality improvement projects. Under a limited degree of supervision, provides support to clinical research studies.
Has general awareness of safety, quality control, and quality assurance procedures. Maintains quality and safety control measures for the laboratory.
Conducts new tests and researches on new technologies for implementation in the laboratory. Solves routine or standard problems relating to the collection and management of patient results and data.
Performs other related work as needed.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
Work Experience:
Minimum requirements include knowledge and skills developed through . Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.