Quality Assurance Specialist

WiCell, a leading non-profit stem cell services institute and supporting organization of UW-Madison, seeks an analytical and detail-oriented Quality Assurance (QA) Specialist to join our collaborative team and help uphold the reputation of quality and excellence for which we are known. This position offers the opportunity to make a significant contribution to the advancement of stem cell research within a collaborative and supportive environment.

The QA Specialist will embody WiCell’s culture of quality and values and align daily actions with departmental goals. The QA Specialist requires the ability to evaluate, investigate, problem-solve, and respond to quality-related questions and requests in a deadline-controlled environment under minimal supervision. The QA Specialist plays a pivotal role in upholding the quality and integrity of WiCell's Stem Cell Bank (non-cGMP) and characterization services (cGMP and non-cGMP).

Key responsibilities include:

• Managing quality events: Overseeing and executing processes related to deviations, CAPAs, excursions, complaints, and out of specification events
  
• Conducting investigations: Applying data-driven analysis and critical thinking to support investigations, perform root cause analysis
  
• Perform Risk Assessments: Supporting risk management and implementing risk mitigation strategies
  
• Ensuring compliance: Supporting internal and external audits, conducting supplier qualification and monitoring, batch record review, and supporting maintenance of validated systems
  

• SOP development and maintenance: Drafting, reviewing, and refining Standard Operating Procedures
  
• Review & approval of equipment records: Reviewing and maintaining equipment documentation (calibration, PM, qualification documents, etc.)
  
• Product release: Release of WiCell Stem Cell Bank products which adhere to the highest quality standards, maintaining WiCell's reputation for quality
  
• Upholding regulatory standards: Ensuring compliance with all applicable domestic and international regulations and quality standards associated with cGMP testing services WiCell offers
  

• Scientific impact: Contribute to the advancement of cutting-edge stem cell research and positively influence the field
  
• Professional development: Opportunities for growth including milestone bonuses for ASQ certifications and special projects
  
• Employee-focused culture: We value work-life flexibility and offer a supportive environment
  
• Excellent benefits: Competitive compensation, comprehensive benefits package (health, dental, 401(k) with match, generous PTO, parental leave, wellness programs, and more)
  

• Experience: A minimum of 5 years in GMP quality assurance or compliance within the pharmaceutical or biotech industries
  
• Education: Bachelor's degree in a scientific field, an associate degree in a related technical discipline, or equivalent experience
  

We encourage all individuals interested in this opportunity to apply via the apply button.

WiCell promotes and supports an inclusive environment and encourages all individuals to apply if you believe you can learn and perform the required responsibility of this position. If you feel you can do the job and are excited about it but not sure if you meet the qualifications, consider applying as we’d love to connect with you!

Our recruitment process for this position will include resume review, phone interview, virtual interview, and an on-site interview for candidates selected to move forward.

We are committed to working with and providing reasonable accommodations to individuals with disabilities throughout the employment process. If you need to request accommodation, please contact Human Resources at 608-960-9838.

Applicants must be authorized to work for any employer in the United States. We are unable to sponsor or take over sponsorship of an employment visa.