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 â“ 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 Gâ™Xâ™P (GLP, GTP, GMP, GDP) guidelines as directed.
1) Working knowledge of Gâ™Xâ™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.
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
The University of Chicago is an Affirmative Action/Equal Opportunity/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 the 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: 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.
Internal Number: JR06085
About University of Chicago
One of the world's premier academic and research institutions, the University of Chicago has driven new ways of thinking since our 1890 founding. Today, UChicago is an intellectual destination that draws inspired scholars to our Hyde Park and international campuses, keeping UChicago at the nexus of ideas that challenge and change the world.