In compliance with FDA and DEA regulations, coordinates the operational systems and performs as necessary, the technical activities associated with the manufacturing of non-sterile dosage forms. Duties to include:
* Document procedures according to established regulatory guidelines. * Follow regulations and procedures for handling and recording raw materials including hazardous/regulated chemicals * Clean or prepare manufacturing areas using odorous compounds. A respirator is provided. * Participate in equipment validations. * Confirm compliance with standard operating & safety procedures during all manufacturing phases of the project. * Prepare standard operating procedures for new equipment and processes.
Manufacturing * Troubleshoot moderately complex production equipment. * Ability to use software ((i.e. word processing, spreadsheets, 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 formulas and standard operating procedures. * Enter data in project batch records and gather other data as needed to complete related reports. * Assist with packaging of product for shipping and preparation of all necessary documentation as directed.
For a full job description, please send an e-mail to the contact listed below.
About University of Iowa Pharmaceuticals (UIP): University of Iowa Pharmaceuticals is a Food and Drug Administration-registered pharmaceutical manufacturing facility, providing expertise in contract pharmaceutical development services to clients around the world. This is an exciting time to join UIP, as the business continues to grow in capabilities, new clients and revenue. In 2020 the College of Pharmacy will be moving into a new $96.3 million College of Pharmacy building. The lower level of this new building will be home to the UIP new sterile products manufacturing area which will be approximately 16,000 square feet and will increase UIP batch size capacity approximately 5-fold to 20,000 vials/batch.
* Bachelor's Degree or equivalent combination of education and experience in a manufacturing environment.
* Ability to effectively and accurately exchange, transmit, receive, and interpret ideas, information and needs with team members through appropriate communication methods. * Ability to efficiently adapt to changes or difficulties and adjust tactics accordingly utilizing learning opportunities. * Working proficiency revising electronic word processing and spreadsheet documents. * History of collaboration and embracing diversity, positive impact/achieving results, service excellence/customer focus. * Demonstrated ability to independently and accurately perform detailed work following precise written procedures. * Experience successfully learning new procedures and equipment.
Direct pharmaceutical manufacturing experience
* current Good Manufacturing Practices (cGMP) or similar regulations * Chemical Safety or Personal Protective Equipment * Manufacturing equipment maintenance
Application Details: In order to be considered for an interview, applicants must upload a resume and cover letter and mark them as a "Relevant File" to the submission. Job openings are posted for a minimum of 14 calendar days and may be removed from posting and filled any time after the original posting period has ended. Successful candidates will be subject to a criminal background check and credential check. Up to 5 professional references will be requested at a later step in the recruitment process.
The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, national origin, age, sex, pregnancy, sexual orientation, gender identity, genetic information, religion, associational preference, status as a qualified individual with a disability, or status as a protected veteran.
Internal Number: 20002253_1589550593
About University of Iowa
With over 31,000 students, the University of Iowa is one of the nation's top public research universities, a member of the Big Ten conference and the Association of American Universities. The University of Iowa is composed of eleven colleges and is known around the world for its balanced commitment to the arts, sciences, and humanities. It is home to one of the nation's largest academic medical centers and the pioneering Iowa Writers' Workshop. The University of Iowa promotes work/life integration and is located in the casual yet cosmopolitan environment of Iowa City, widely recognized as one of the country's most livable communities.