Product Specialist

University of Iowa•Iowa City, IA

13d

About The Position

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.

Requirements

Bachelor’s Degree or equivalent combination of education and experience.
Effective communication (written and verbal).
Proficiency revising electronic word processing and spreadsheet documents.
Proven attention to detail and ability to follow lengthy procedures.

Nice To Haves

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

Responsibilities

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.
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.
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.

Benefits

Regular salaried position.
Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans.
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.

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