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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

Imagine having the opportunity to develop a completely new therapeutic area, serving patients with limited treatment options in highly unmet medical needs. Imagine developing those therapeutics and serving those patients in an environment that is fundamentally science-first, data-driven, and relentless in serving patients. Then imagine being able to build capabilities, infrastructure, teams, and truly differentiated manufacturing processes from the ground up. Finally, imagine doing that, and within the same organization, walking across the hallway and immediately exploring a new product\'s safety and benefit in patients.

The Duchossois Family Institute (DFI) at the University of Chicago seeks a Quality Assurance Specialist for our current Good Manufacturing Practices (cGMP) facility. This facility will be a first of its kind, state-of-the art, adaptable microbiome manufacturing center embedded at the interface of a world-class microbiome sciences research team and patient-centric medical center aimed at translating innovation at the bench to investigations in the clinic. Our objective is to embed a biotech, product development-focused capability within an advanced academic research environment, all towards driving value for patients in addressing unmet medical needs in record time. The DFI\'s goal is to optimize or augment microbiome functions that enhance disease resistance. The QA Specialist is responsible for all aspects of Quality Assurance related to internal processes and manufacturing activities that will take place within the DFI cGMP Facility. This individual will be responsible for ensuring that manufactured products meet standards of quality, reliability, and safety.

Responsibilities

• Oversee the electronic Documentation, Change Control and Training system.
• Implement the Quality Management System (QMS) for the organization.
• Manage and oversee equipment installation and calibration activities.
• Establish Standard Operating Procedures (SOPs) and specifications for various quality and manufacturing processes.
• Collaborate with the purchasing / inventory specialist to ensure raw materials from external suppliers meet quality requirements.
• Manage incoming inspection of raw material for cGMP use.
• Establish Vendor score cards and perform supplier audits for critical vendors.
• Review Production Batch Records and manage disposition of material at each step of the manufacturing process.
• Collect, compile, and analyze relevant quality data and obtain information regarding quality performance.
• Manage non-conformance reports (NCRs) and trend non-conforming data regarding product and processes.
• Conduct quality control tests / inspections to verify quality of incoming material and finished goods.
• Review existing processes, specifications, and documents and identify improvement opportunities as seen fit.
• Supports data collection and analytical needs of research projects. Conducts literature reviews and helps write reports and manuscripts. Ensures project compliance with different policies, procedures, directives, and mandates.
• Takes responsibility for the following on-laboratory duties: transcribing and coding data; developing data collection instruments; presenting research; and recruiting and scheduling research subjects. Acquires higher-level skills and knowledge in the process.
• Takes responsibility for the following laboratory duties: recognizing abnormal results and varying conditions or procedures to correct problems; setting up and performing experiments. Analyze the meaning, significance, causes, and effects of the subject.
• Performs other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.

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Work Experience:

Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Education:

• Bachelor\'s degree in business management or administration, Biology or Bioengineering or related fields.

Experience:

Previous quality assurance role in biopharmaceutical development or manufacturing setting, either ac