Senior Quality Assurance Specialist
Bio-Techne · Newark, CA
QualityFull-time$89k–$147kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Senior Quality Assurance Specialist responsible for implementing systematic quality activities, conducting audits, and ensuring regulatory compliance at a life sciences company. The role involves document control, CAPA management, validation activities, and preparation for regulatory inspections.
What they're looking for
- Bachelor's degree in science, engineering, or related field
- Minimum 8 years of quality assurance function experience
- Lead auditor certification or ASQ CQE/CQA certifications preferred
- Proficiency with document control processes and electronic databases
- Strong understanding of ISO 13485, FDA Quality System Requirements, and ISO 14971
- Advanced Microsoft Office skills including Excel for data analysis
- Demonstrated ability to lead investigations and determine material dispositions
What you'll be doing
- Manage document control activities using electronic database systems
- Conduct and report on periodic internal audits per established schedule
- Review batch records and assist with material release or hold decisions
- Write, review, and revise nonconformances, CAPAs, and quality procedures
- Prepare validation plans and reports; execute validation activities
Privacy & handoff
This role links to Bio-Techne's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.