Manufacturing Specialist
University of Iowa

Job Info

---

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.

Key Areas of Responsibility:

Compliance

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.

Manufacturing

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.

Leadership

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.

For a complete job description, 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 diverse 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:
  • 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 subject to a criminal background and credential check. 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

• Regular salaried position. 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 Iowa? Click here.

Additional Information

• Classification Title: Product Specialist
• Appointment Type: Professional and Scientific
• Schedule: Full-time

Compensation

• Pay Level: 3A
• Starting Salary Minimum: 45,320
• Starting Salary Maximum: commensurate

Contact Information

• Organization: College of Pharmacy
• Contact Name: Libby Kleppe
• Contact Email: libby-kleppe@uiowa.edu

This job has expired.