Quality & Operational Improvement Coordinator

University of Iowa

Job Reference #: 19004494

University of Iowa Pharmaceuticals (UIP), a division of the College of Pharmacy, is seeking applicants for a full-time Quality and Operational Improvement Coordinator. This position will report to the Director of Manufacturing Quality and will provide technical writing support to all operations of UIP. Specific duties include detailed writing of Standard Operating Procedures (SOPs), Qualification Documents (IQ, OQ, PQ) of various pieces of pharmaceutical manufacturing equipment, training of staff on SOPs, and support of the Manufacturing Quality Department. This is of particular importance as UIP prepares to bring a new aseptic processing facility online. This individual works closely with the Manufacturing Quality team, senior UIP staff, and other assigned departments within UIP.
Other duties include:
  • Process Improvement, Quality Engineering, and Managing Engineering Concepts and Methodologies- Assist with the cGMP documentation preparation required for the new manufacturing facility, including but not limited to the writing, review and editing of SOPs for Sterile products, Inspection and Label Control, Facilities and Manufacturing Quality.
  • Collect and Analyze Data- Assist in generating an environmental monitoring document for new manufacturing lines based on a risk assessment of available EM data provided during media fill validation, SAT and other commissioning activities. 
  • Quality Assurance and Compliance- Document procedures according to established regulatory guidelines CFR 210/211 cGMP/USP/ICH/EP. 
  • Training/Education- Assist GMP training as needed to facilitate quality and process improvement initiatives.
For a full job description, please send an email 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.
Required Qualifications:
  • Bachelor’s Degree in English or a technical field (basic sciences or engineering) or an equivalent combination of education and experience.
  • Minimum 3 years’ experience performing technical writing in a manufacturing environment or related technical field (basic sciences or engineering). 
  • Strong communication (written and verbal) and organizational skills.
  • Proven ability to filter complex technical documents into concise, logical and easy to interpret Standard Operating Procedures and regulatory ready documents. 
Desirable Qualifications:
  • 2-3 years demonstrated experience in technical writing in the pharmaceutical industry or a related field.
  • Experience with Food and Drug Administration (FDA) current Good Manufacturing (cGMP) or similar regulations. 
  • Demonstrated experience collecting and analyzing data and/or developing and delivering training programs. 
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.

Job ID: 69580

Posted 30 days ago

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