Manufacturing Specialist

University of Iowa•Iowa City, IA

23d•Onsite

About The Position

The University of Iowa Pharmaceuticals is seeking a Manufacturing Specialist to join the team. 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. 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

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
Demonstrated ability to independently and accurately perform detailed work following written procedures.
Experience learning new procedures and equipment.

Nice To Haves

Experience in a manufacturing environment.
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.

Responsibilities

With oversight, maintain and document compliance with FDA and DEA regulations and safety procedures related to manufacturing, sampling, labeling, and inspection processes and equipment during their use within a sub-unit.
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.
Conduct and oversee the setup, operation and troubleshooting of manufacturing systems with a high degree of proficiency using established procedures and working under a moderate level of supervision.
Interact with clients as necessary and under supervision to assure their projects are completed in an appropriate manner.
Schedule equipment and production runs; procure required supplies.
Produce production run reports.
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.
Assure staff comply with federal and state regulations and SOPs.
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.