Product Specialist

The University of Iowa Pharmaceuticals is seeking a Product Specialist to join the team. In compliance with FDA and EMA regulations, completes and coordinates quality assurance activities within Inspection, Labeling and Control to support the pharmaceutical manufacturing of various dosage forms.

About the University of Iowa Pharmaceuticals

UI Pharmaceuticals is a Contract Development and Manufacturing Organization (CDMO) within the College of Pharmacy at the University of Iowa. Our mission is to improve quality of life by applying our pharmaceutical expertise to advance innovative products into clinical trials. Our vision is to be the premier partner for biotech, government, and research institutions.

We are located on the main campus in Iowa City, which offers a great place to live, top rated schools, a vibrant night life, and world class health care facilities. As a University of Iowa employee, you will have access to an excellent benefits package.

Key Areas of Responsibility

Compliance

• Document procedures according to established regulatory guidelines.
• Completes appropriate training documentation.
• Follow regulations and procedures for handling hazardous/regulated chemicals.
• Complete and pass product qualifications prior to inspections of various product forms.
• Participate in equipment validations.

Manufacturing

• Count, wipe, inspect, label, package and store finished product following batch record and SOP requirements for various product forms.
• Uses software (i.e. word processing, spreadsheets, database, email, and equipment operating/data collection software) relevant to manufacturing duties.
• Setup, operate, clean, and maintain ILC equipment following standard operating procedures.
• Enter data in project batch records and gather other data as needed to complete related reports.
• Assist with the disposal of unused finished products, rejected products, remaining solutions, and other miscellaneous products.

Leadership

• Assure staff comply with federal and state regulations and SOPs.
• Participate in cross-training in order to be able to perform functions across sub-unit boundaries.

To obtain the full job description including key areas of responsibility, technical competencies, and desirable qualifications, please contact Libby Kleppe at libby-kleppe@uiowa.edu.

Education Requirement

• Bachelor's Degree or equivalent combination of education and experience.

Experience Required

• Effective communication (written and verbal).
• Proficiency revising electronic word processing and spreadsheet documents.
• Proven attention to detail and ability to follow lengthy procedures.

Highly Desirable Experience

• Experience working in quality control, inspections, or a regulated industry.

Desirable Experience

• Experience in a manufacturing environment.
• Experience with Standard Operating Procedures.
• Experience setting up, operating, performing preventive maintenance, and troubleshooting equipment.
• Knowledge and experience handling hazardous substances.

Application and Position Details

• In order to be considered for an interview, applicants must upload the following documents and mark them as a "Relevant File" to the submission:
  • Resume
• Job openings are posted for a minimum of 14 calendar days. This job may be removed from posting and filled any time after the minimum posting period has ended. Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. 5 professional references will be requested at a later step in the recruitment process. For additional questions, please contact Libby Kleppe at libby-kleppe@uiowa.edu.

Benefits Highlights

• Regular salaried position. Pay level 3A. Located in Iowa City, Iowa.
• Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans.
• For more information about Why Iowa? Click here.

Joining the University of Iowa means becoming a vital part of the Hawkeye community, where your work directly impacts education, research, and student success.

Enjoy exceptional health coverage, university-paid life insurance, robust retirement plans, and generous leave policies. Benefit from 24/7 support services, well-being resources, and access to UI Health Care specialists. Grow professionally with advanced training, leadership development, and tuition assistance.

Iowa City offers a great quality of life with world-class performances at Hancher Auditorium, Big Ten athletics, top-ranked public schools, and outdoor recreation.

Join us in making a difference at a leading Big Ten university and premier public research institution.

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