TheCollege of Pharmacyis seeking aManufacturing 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.
About the University of Iowa Pharmaceuticals
UI Pharmaceuticalsis a Contract Development and Manufacturing Organization (CDMO) within theCollege of Pharmacyat the University of Iowa. Our mission is toimprove quality of lifeby applying our pharmaceutical expertise to advance innovative products into clinical trials. Our vision is to be thepremier partnerfor 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 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
- Participate in cross-training with other manufacturing departments.
- Utilizes learning opportunities to prepare for dynamic and changing work environment.
- 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 anddesirable qualifications please contact Libby Kleppe at
Education Requirement
- Bachelors 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.
- Demonstrated ability to independently and accurately perform detailed work following written procedures.
- Experience learning new procedures and equipment.
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:
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
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 IowaClick 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.
Additional Information
Compensation
Contact Information
Required Experience:
Unclear Seniority