Quality Assurance Specialist

Overview

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 contribute to the advancement of stem cell research within a supportive environment.

• 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 and 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
• Document control: Utilizing the electronic Quality Management System (eQMS), Qualio, to ensure accurate, organized, and compliant project-related documentation
• 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 high quality standards, maintaining WiCell's reputation for quality
• Upholding regulatory standards: Ensuring compliance with applicable domestic and international regulations and quality standards for cGMP and related services

• 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

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

This is a full-time, onsite position at 504 S. Rosa Road in Research Park, Madison.

We encourage all individuals interested in this opportunity to apply via the apply button. WiCell promotes an inclusive environment and encourages all individuals to apply if you believe you can learn and perform the responsibilities of this position.

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 providing reasonable accommodations to individuals with disabilities during the employment process. If you need to request accommodation, please contact Human Resources at .

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.

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Biotechnology, Research and Non-profit Organizations

We’re unable to sponsor visas. This description reflects the current responsibilities and requirements of the role.