Quality Assurance Specialist

WiCell; Madison (WI); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation

Comprehensive benefits package

Professional development opportunities

Work-life flexibility

Job summary

A leading non-profit stem cell services institute in Madison is seeking a Quality Assurance (QA) Specialist. This full-time, onsite role requires a minimum of 5 years' experience in GMP quality assurance. Responsibilities include managing quality events, conducting investigations, and ensuring compliance with regulations. Competitive compensation and comprehensive benefits are offered in a supportive work environment.

Qualifications

• Minimum of 5 years in GMP quality assurance or compliance within the pharmaceutical or biotech industries.
• Experience with data-driven analysis and critical thinking.

Responsibilities

• Managing quality events by overseeing relevant processes.
• Conducting investigations and performing root cause analysis.
• Ensuring compliance with regulatory standards and quality standards.

Skills

GMP quality assurance

Compliance

Data-driven analysis

Root cause analysis

Education

Bachelor's degree in a scientific field

Associate degree in a related technical discipline

Job description

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.

What you will do

• 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

What you bring

• 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

Why WiCell

• 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)

Location

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

To Apply

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 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.

Job details

• 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.