Quality Assurance Manager
About the role
The QA Manager will embody WiCell’s culture of quality and values and align daily actions with departmental goals. The QA Manager requires the ability to evaluate, investigate, solve problems, and respond to quality-related questions and requests in a deadline-controlled environment.
Responsibilities
- Implement, update and support and maintain various aspects of quality systems: including training document control, safety, information management and equipment
- Manage QA Test tracking and product release: of WiCell Stem Cell Bank products which adhere to the highest quality standards, maintaining WiCell's reputation for quality
- Review and assign workload to QA Team: including QC reports, characterization reports, batch records, vendor reports, version-controlled documents and quality events
- SOP development and maintenance: Approve, draft, revise and implement standard operating procedures (SOPs), and other regulatory requirements
- Manage internal and external audits: maintain audit schedule and forms and act as lead auditor during audits
- Managing quality events: such as investigation (CAPA) and deviations, including identifying preventative actions and corrective actions
Requirements
A minimum of 4-5 years in GMP quality assurance or compliance within the pharmaceutical or biotech industries. Experience in sterile culture techniques or culturing mammalian cells is preferred, but not required.
Qualifications
A Bachelor's degree in a biological scientific field, an associate degree in a related technical discipline, or equivalent experience.
Skills
Quality Assurance training (i.e., ASQ certifications) preferred, but not required.
Pay
Competitive compensation.
Schedule
Full-time, onsite position at 504 S. Rosa Road in Research Park, Madison.