Manufacturing Specialist
The College of Pharmacy is seeking a Manufacturing Specialist. Under the direction of the Manufacturing Supervisor at UI Pharmaceuticals, this position coordinates the operational systems and performs as necessary, the technical activities associated with the manufacturing of sterile dosage and non-sterile dosage forms while ensuring compliance with the Food and Drug Administration (FDA) and the Drug Enforcement Agency (DEA) regulations.
Key Areas of Responsibility
Compliance
- Document procedures according to established regulatory guidelines.
- Completes appropriate training documentation
- Follow regulations and procedures for handling and recording raw materials including hazardous/regulated chemicals.
- Follow aseptic technique during manufacturing process. May include gowning and the use of personal protective equipment.
- Clean or prepare manufacturing areas using odorous compounds. A respirator is provided.
Manufacturing
- Responsible for equipment coordination to be used in manufacturing rooms. Works with department personnel to ensure the equipment is ready for use and available when needed.
- Use software (i.e., word processing, spreadsheets, inventory database, email, specialized environmental systems control software and equipment operating/data collection software) relevant to manufacturing duties.
- Setup, operate, clean, and maintain a variety of complex equipment, which may include standing for periods of over two hours at a time, used in the preparation of various pharmaceutical dosage forms in accordance with prepared project batch records and standard operating procedures.
- Enter data in project batch records and gather other data as needed to complete related reports following cGMP.
- Assist with the disposal of unused components, unused finished products, and unused rejected products.
Leadership
- Identify and suggest improvements associated with standard operating procedures and manufacturing guidelines.
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 in a manufacturing environment.
Experience Required
- Demonstrated ability to effectively and accurately exchange, transmit, receive, and interpret ideas, information and needs with team members through appropriate communication methods.
- Proven record of effectively adapting to changes and adjusting tactics in order to solve business problems.
- Experience using or knowledge of Microsoft Office or comparable software (i.e., Word, Excel).
- History of working collaboratively and professionally within a varied work environment.
Desirable Qualifications
- Experience performing either sterile or non-sterile processes and/or equipment maintenance.
- Experience in a manufacturing environment and/or highly regulated environment.
- Involvement with chemical safety, confined space, or personal protective equipment.
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
- Cover Letter
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
- 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.
Equal opportunity employer
The University of Iowa is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, religion, national origin, age, sex, pregnancy (including childbirth and related conditions), disability, genetic information, status as a U.S. veteran, service in the U.S. military, sexual orientation, or associational preferences.
Persons with disabilities who need assistance or accommodations with the application or interview process may contact University Human Resources/Faculty and Staff Disability Services, (319) 335-2660 or fsds@uiowa.edu. For jobs in UI Health care, please contact UI Health care Leave & Disability Administration at 319-356-7543.
