Quality & Operation Improvement Coordinator

University of Iowa

Iowa City, IA Scientific / Manufacturing & Industrial

Job Reference #: 19004260

Seeking a key member to the Laboratory Quality group of the University of Iowa Pharmaceuticals to ensure compliance to UIP SOPs, methods and protocols for analytical testing. This position generates, reviews and/or approves reports based on analytical test results, coordinates Standard Operating Procedure (SOP) revisions and SOP training and stability studies, ensures accuracy and completeness of laboratory equipment calibration & maintenance database.
Duties to include:
  • Consults with and collects data from UIP manufacturing group, chemists, and contract analytical labs to generate reports for products.
  • Writes, revises and reviews SOP's in accordance with industry expectations and guidelines. Involves consultation with colleagues to ensure best practice.
  • Performs quality assurance services to support analytical Good Manufacturing Processes laboratory.
For a full job description, please send an email to the contact listed below.

About the University of Iowa Pharmaceuticals
 The University of Iowa Pharmaceuticals (UIP) division of the College of Pharmacy seeks qualified applicants for a full-time Quality and Operational Improvement Coordinator in the Laboratory Quality department. This position will report to the Director, Laboratory Quality and will plan, direct, and coordinate development projects for client pharmaceutical and biotechnology organizations. This position is located on the UI Research Campus.

 The UIP 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, a new $96.3 million College of Pharmacy building is scheduled to open in 2020. 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.
Qualifications
 Required Qualifications:
  • Bachelor’s degree in the Sciences or an equivalent combination of related education and experience.
Experience, typically 1-3 years, in the following:
  • Documentation and change control according to Good Manufacturing Processes or similar regulations
  • Performing quality assurance/quality control functions, auditing and/or process improvement 
  • Written and verbal communication skills; ability to effectively transmit, receive, and accurately interpret ideas, information and needs through appropriate communication methods and behaviors
  • Commitment to diversity in the work/academic environment; ability to effectively interact with a variety of people in a team environment
  • High-Performance Liquid Chromatography (HPLC) analysis using Empower 
  • Microsoft Word and Excel or comparable software
Desirable Qualifications:
  • Bachelor’s degree in Chemistry
Knowledge and/or experience, typically 1 year, in:
  • United States Pharmacopeia and European Pharmacopeia training
  • Trend analysis
  • Microsoft Access database or other relational database 
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.

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.

Application Instructions:

Successful candidates will be subject to a credential and criminal background check. Up to 5 professional references will be requested at a later step in the recruitment process.

Job ID: 69535

Posted 4 days ago

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