Perform environmental monitoring in the Production Areas including but not limited to: dynamic monitoring for campaigns, biweekly particle counts and monthly air samples and prepare reports.
Perform personnel monitoring for required campaigns.
Assist in the set up new lab equipment used in Quality Control Laboratory and assist with upkeep such as setup, temperature monitoring, daily verification with QC, instrument/operation/performance qualifications (IQ/OQ/PQ), routine maintenance, troubleshooting.
Support cGMP compliance through validation and qualification of processes, material and supplies, equipment and facility processes, perform vendor qualification of manufacturing supplies and material.
Ensure all equipment are operating correctly.
Ensure all materials and samples are stored correctly at the right temperatures.
Help monitor and maintain compliance with institutional, state, and federal regulatory policies and procedures and accrediting organizations.
Process supply orders on Buysite and through pharmacy, processes inventory-obtain quality certificates (Certificate of Analysis, Certificate of Sterility, Certificate of Conformance, etc.) for all items.
Prepare kits of supplies used in manufacturing for all campaigns.
Maintain inventory levels for facility operations, vaccine preparations, cell therapy, and islet preparations.
Assist in facility expansion projects with the Technical Director and QA/QC Manager.
Assist in instrumentation error reports and deviations.
Perform room change-over in facility after campaigns with specialized cleaning to maintain GMP fashion.
Assist with facility repairs/maintenance with University of Chicago Plant personnel and vendors.
Attend all required training and comply with all safety and operations procedures.
Perform all other duties as requested by the Technical Director or QA/QC Manager.
Cellular Processing and Manufacturing.
Provide backup support to variety of cellular product processing procedures under Gâ™Xâ™P (GLP, GTP, GMP, GDP) guidelines as directed with speed and accuracy.
Provide backup support to variety of cellular infusion procedures under GTP guidelines as directed with speed and accuracy.
Transport prepared vaccines/cell therapy products to the clinic or pharmacy.
Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
Performs other related work as needed.
Bachelor's degree in biology, medical laboratory science, medical technology, molecular/bio-engineering, or closely related field.
Graduate degree strongly preferred.
Post-bachelor laboratory experience, preferably in immunology, biochemistry, molecular biology, microbiology, or a related field.
Experience in equipment maintenance and validation strongly preferred.
Working knowledge of quality control and cGMP.
Advanced skills with Microsoft Office Suite.
Ability to work in a cGMP sterile clean room setting.
Ability to read and write and follow documents including protocol and SOPs.
Capacity to handle multiple tasks and competing demands under tight timeframes.
Execute and comply with all oral and written procedures including Batch Records and SOPs.
Attention to detail.
Ability to demonstrate excellent interpersonal and communication skills.
Strong emphasis on documentation according to FDA regulations and other regulating bodies.
Excellent verbal and written communication skills.
Capacity to exhibit organizational skills.
Ability to work in a collaborative team environment.
Ability to work under pressure, manage competing deadlines and priorities in a fast-paced environment.
Ability to understand, retain, and carry out instructions and solve problems in complex situations.
Ability to independently learn new techniques.
Ability to interact with all levels of staff in a professional manner while respecting patient confidentiality.
Excellent customer/staff interpersonal skills.
Must be detail-oriented, well organized and approach procedures with critical thinking of the technical aspects with strong communication skills and ability to work in an interactive team environment.
Must be able to manage multiple and rapidly changing priorities and have ability to quickly learn new skills.
Ability to perform light/medium work, which includes lifting up to 30 pounds.
Occasionally must bend, twist, squat, climb, reach, stoop, and kneel.
Ability to be mobile walking from building to building.
Ability to sit for some period of up to 2 hours.
All employees within this job classification may have exposure to blood-borne pathogens, other potentially infectious materials, and/or hazardous chemical waste.
Cover Letter (preferred)
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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.
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