Quality Assurance Reviewer
University of Iowa

Job Info

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UI Pharmaceuticals, located in the College of Pharmacy, is an FDA registered contract development and manufacturing facility of pharmaceutical parenteral and various non-sterile dosage forms. The Quality Assurance (QA) group is responsible for ensuring adherence to recognized standards resulting in high quality results in our manufacturing and laboratory facilities.

The Quality Assurance Reviewer position works under supervision from the Quality Manager to ensure compliance to both Federal and International statutory law and agency guidelines. The role ensures products leaving the facility meet the necessary strength, integrity, safety, purity, and quality required by current Good Manufacturing Practices (cGMP). In addition, the position will report relevant findings to senior leadership and UIP staff to promote corrective action and continuous improvement in the organization.

Key Areas of Responsibility

Quality Assurance and Compliance

• Audits and reviews executed manufacturing batch records and associated documents to ensure accuracy and completeness.
• Audits and reviews laboratory data in notebooks according to existing methods to ensure accuracy and completeness.
• Performs reviews of complex method qualifications/validations using general USP, EU or ICH guidelines or Standard Operating Procedures (SOPs).
• Collects data for writing investigations, deviations, or incident reports per SOPs.
• Archives data and maintains required records of production/analyses.
• May provide recommendations to identify and address root causes.
• Legibly documents procedures according to established regulatory guidelines CFR 210/211 cGMP/USP/ICH/EP.
• Writes, revises, and reviews SOPs in accordance with industry expectations and guidelines.
• Follows standard operating procedures and performs biennial reviews of SOPs.
• Reviews metrology results from manufacturing or the laboratory for compliance with SOPs.
• Review and approve client specific laboratory methods.
• Provide feedback to analysts or operators regarding documentation errors.
• Writes qualification documents and execute metrology activities in the organization.
• Correspond with departments regarding Out of Trend (OOT), Out of Specification (OOS) and other investigations to provide information and collaborate for problem resolution.

Human Resources

• Establish and maintain standards for interpersonal interactions.

Training/Education

• Participates in GMP training as needed.
• Participates in UI training as needed.
• Assists with staff training on applicable SOPs as needed.
• Participates in cross-training for departments as necessary.

For a complete job description, please contact Libby Kleppe at libby-kleppe@uiowa.edu

Required Qualifications

• Bachelor's Degree or equivalent combination of education and experience in quality assurance or related field.
• Working use of Windows based computer systems.
• Ability to use attention to detail and to work simultaneously on different projects.
• Strong communication (written and verbal) and organizational skills.
• Must have valid driver's license and be able to meet the University of Iowa Fleet Management Driver's safety requirements.

Desirable Qualifications

• 2-3 years of demonstrated experience in Quality Assurance in the pharmaceutical industry or a related field.
• Experience with Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMP).
• Experience analyzing manufacturing or laboratory techniques and procedures used in life sciences industry.

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: Qual & Op Improv Coordinator
• Appointment Type: Professional and Scientific
• Schedule: Full-time

Compensation

• Pay Level: 3A
• Starting Salary Maximum: 55,875

Contact Information

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

This job has expired.