Temporary cGMP Operations Intern

University of Chicago•Chicago, IL

1d•$18 - $22

About The Position

Under the supervision of the Technical Director and facility manager of the cGMP Core, the Temporary cGMP Operations Intern will assist cGMP staff in facility operations of the core. This internship is a great opportunity to introduce the individuals to clinical research, cGMP facility operations and maintenance, and cell & gene therapies at the University of Chicago. The ideal candidate should be a self-starter and be responsible for maintaining strict compliance under various regulatory agencies and detailed record keeping.

Requirements

Ability to work in a cGMP sterile clean room setting is required.
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 in the SOPs.
Attention to detail.
Ability to demonstrate excellent interpersonal and communication skills; required.
Excellent verbal and written communication skills.
Capacity to exhibit organizational skills; required.
Ability to work in a collaborative team environment.
Ability to understand, retain, and carry out instructions and solve problems in complex situations.
Ability to interact with all levels of staff in a professional manner while respecting patient confidentiality.
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.
High School Diploma required.
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.

Nice To Haves

Experience with Microsoft Office Suite preferred
A minimum of 1-2 year of science laboratory courses
Significant progress towards their degree in a science discipline preferred.

Responsibilities

Perform environmental monitoring in the Production Areas including biweekly particle counts and monthly air samples and prepare reports.
Assist in the set-up of lab equipment and new cleanrooms used in the cGMP core and assist with upkeep such as setup, temperature monitoring, daily verification with QC, routine maintenance, troubleshooting.
Assist in cGMP compliance through validation and qualification of processes, maintaining inventory of materials and supplies, equipment, and facility processes.
Process supply orders and obtain quality certificates (Certificate of Analysis, Certificate of Sterility, Certificate of Conformance, etc.).
Prepare kits of supplies used in manufacturing for all campaigns.
Perform cleanroom change-over in facility after campaigns with specialized cleaning to maintain cGMP fashion.
Attend all required trainings and comply with all safety and operations procedures.
Learn basic laboratory techniques for cell therapy such as manual cell counting, automated cell counting, endotoxin testing, cell freezing.
Performs various aspects of clinical research, such as collecting and processing specimens, interviewing subjects, taking vital signs, and contributing to the case report.
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.
Perform all other duties as requested by the Technical Director or QA/QC Manager.
Performs other related work as needed.