University of Chicago Environmental Health & Safety Technician in Chicago, Illinois
Please make sure to read the job posting in its entirety as it reflects both the University roles and responsibilities, followed by the specific description.
20114 BSD Shared Research Facilities
About the Unit
The University of Chicago cGMP Core which is part of the Biological Sciences Division (BSD) offers a state-of-the-art controlled laboratory environment as well as resources and consultative services for preparing cellular and biological products for human clinical trials. The Facility is FDA registered and follows regulations set forth by 21CFR Part 1271, which outlines requirements for preparing human cells, tissues and tissue-based products for treating patients.
Legal & Regulatory Affairs
Responsible for providing advice and services to University officials on legal issues associated with the University’s activities, including transactional and intellectual property matters, policy formulation and compliance, employment and student issues, and pre-litigation dispute resolution. Represents the University’s interests in administrative and judicial proceedings. Holds primary institutional responsibility for establishing and maintaining relationships with regulatory and other governmental entities, and establishing and maintaining related compliance policies and protocols.
Career Track and Job Level
Environmental Health & Safety
Designs, develops, and implements environmental, health, and safety programs and procedures for the University and the surrounding community. Enables effective and compliant work practices that ensure a healthy and safe educational and work environment. Ensures that all facilities are in compliance with regulations, and directly engages state and federal workplace safety agencies.
T2: Expands skills in own work area within an analytical/scientific method or operational process. Maintains appropriate licenses, training and/or certifications, as needed. Applies experience and skills to complete assigned work within our area of expertise. Works within standard operating procedures and/or scientific methods. Works with a moderate degree of supervision.
The job provides technical support activities related to the design, development, and implementation of environmental, health, and safety programs and procedures for the University and the surrounding community. Provides support to enable effective and compliant work practices, ensuring a healthy and safe educational and work environment. Works within defined processes and procedures to ensure that all facilities are in compliance with regulations, and engages state and federal workplace safety agencies. Completes work with a moderate degree of supervision.
1) Under a moderate degree of supervision, assists in the implementation of the University's environmental health and safety programs to safeguard employees and ensure legal compliance., 2) Works within defined processes to conduct inspections and tests of instruments, laboratories and/or other facilities to ensure proper functioning and compliance with government laws and University policies., 3) Compiles data and assists with preparing reports. Performs data entry and helps maintain required documentation., 4) Completes a variety of assignments, such as equipment calibration, specialized cleaning, and waste storage and removal, as needed., 5) Performs other related work as needed.
1) Helps monitor and maintain compliance with institutional, state, and federal regulatory policies and procedures and accrediting organizations.
2) Support cGMP facility operation including validation and qualification of processes, material and supplies, equipment and facility processes, perform vendor qualification of manufacturing supplies and material.
3) Take biweekly particle counts in the Production Areas and prepare report, take environmental monitoring samples monthly in production areas (with Rodac Plates).
4) Processes supply orders on Buysite and through pharmacy, processes inventory – obtains certificates (Certificate of Analysis, Certificate of Sterility, Certificate of Conformance, etc.) for all items.
5) Stock Facility and supporting areas with supplies and gowns.
6) Maintain inventory levels for facility, vaccine preparations, cell therapy and islet preparations.
7) Perform Endotoxin assays as need for Cell Therapy Process.
8) Schedule and prepares microbiology lab forms in 4Medica.
9) Deliver sterility and gram stain samples to Microbiology and obtain results through 4Medica and/or directly with Micro Lab personnel.
10) Prepare kits of supplies used in manufacturing for all campaigns.
11) Perform room change-over in facility after campaigns with specialized cleaning to maintain GMP compliance.
12) Process gowns to Aramark for sterilizing/cleaning and maintains inventory levels.
13) Assist with facility repairs/maintenance.
14) Transport prepared vaccines/cell therapy products to the clinic or pharmacy, test and check eye wash station, change gas tanks and maintain chemical inventory for EH&S.
15) Perform duties as dictated by standard operating procedures (SOPs) for cellular product processing and under G’X’P (GLP, GTP, GMP, GDP) guidelines as directed.
1) Working knowledge of G’X’P.
2) Attention to detail.
3) Ability to demonstrate excellent interpersonal and communication skills.
4) Strong emphasis on documentation according to FDA regulations.
5) Execute and lead operation to comply with all written procedures, to include Batch Records and SOPs.
6) Excellent verbal and written communication skills.
7) Capacity to exhibit organizational skills.
8) Ability to work in a collaborative team environment.
9) Capacity to handle multiple tasks and competing demands under tight timeframes.
10) Ability to work under pressure, manage competing deadlines and priorities in a fast-paced environment.
11) Ability to understand and carry out instructions and solve problems in complex situations.
12) Ability to read and write and follow documents including protocol and SOPs.
13) Ability to independently learn new techniques.
14) Ability to interact with all levels of staff in a professional manner while respecting patient confidentiality.
15) Excellent customer/staff interpersonal skills.
Education, Experience, and Certifications
Minimum requirements include vocational training, apprenticeships or the equivalent experience in related field (not typically required to have a four-year degree).
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.
1) Bachelor's degree in Science or Engineering or closely related field.
1) Year or more experience working in a laboratory environment.
2) Experience with laboratory skills and techniques.
3) Advanced skills with Microsoft Office Suite.
2) Cover Letter
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
Depends on Qualifications
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
Remove from Posting On or Before
The University of Chicago is an Affirmative Action/EqualOpportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.
Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.
The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.
- Posted 30+ Days Ago
- Full time