The University of Iowa Pharmaceuticals invites qualified applicants to apply for the Manufacturing Specialist position in our sterile products manufacturing unit. This position coordinates the operational systems and performs as necessary, the technical activities associated with the manufacturing of sterile dosage forms while ensuring compliance with the Food and Drug Administration (FDA) and the Drug Enforcement Agency (DEA) regulations.
Below are key areas of responsibility.
Document procedures according to established regulatory guidelines.
Completes appropriate training documentation for supervised personnel.
Follow regulations and procedures for handling and recording raw materials including hazardous/regulated chemicals.
Follow aseptic technique for the manufacture of sterile products to prevent microbial contamination. This includes gowning in sterile attire and maintaining sterile conditions throughout the manufacturing process.
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.
Troubleshoot moderately complex production equipment.
Responsible for equipment coordination.
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 the disposal of unused components, unused finished products, and unused rejected products.
Assist with packaging of product for shipping and preparation of all necessary documentation as directed.
Assist with the preparation of master batch records and product specifications.
Participate in cross-training for other manufacturing sections.
Acquire new methods according to standard operating procedures of other manufacturing units.
The information contained herein is not intended to be an exhaustive list of all responsibilities required of individuals performing the job. Please contact Brenda Zobeck (firstname.lastname@example.org) for a copy of the detailed job description.
Note to applicant:The qualifications for this job posting are described as competencies or the behaviors needed to be successful in performing the duties of the position at a defined proficiency level/standard. The proficiency levels required for this position are at the basic and working levels.Please ensure that your resume and/or cover letter illustrates the work experience, knowledge, skills and abilities you have that meet each of the required qualifications.For additional information on competencies, visit: http://hr.uiowa.edu/competencies.
Please note regarding references: Five professional references may be requested and required at a later step in the recruitment process.
Please note regarding cover letter: A cover letter is required as part of the application documents. The purpose of the cover letter is to demonstrate effective written communication skills and attention to detail.
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.