Hiring: Senior Quality Assurance Specialist Company: Bio-Techne Location: Newark, CA Job Posted Time: 2026-09-10 13:49:14 Employment Type: Internship Target Skills & Keywords : Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Quality Assurance, Risk Management About the job Experience: •At least 8 years of experience in a QA function for the Sr. Quality Assurance Specialist role. Required Skills: •Document Control activities using an electronic database •Conduct internal audits on a periodic basis according to an established scheduled plan •Prepare written audit reports and all activities and report findings. •Prepare quality records and for regulatory inspections. •Assist with batch record review and release of approved materials or place material on hold. •Review and/or write nonconformances and CAPAs. Prepare and host Materials Review Board and CAPA Review Board meetings. •Assist with maintaining and monitoring Quality Assurance specific quality indicators. •Help prepare data for Management Review Qualifications: •Demonstrated experience with Document Control processes, experience with an Electronic Database a plus •Demonstrated an understanding of QA regulations and best practices •Excellent verbal and written communication skills, strong interpersonal skills, and a demonstrated ability to manage multiple activities while maintaining a high level of organization. •Working experience as a lead auditor. •Demonstrated capacity to lead nonconforming material investigations, write reports, and determine material dispositions in a timely manner while maintaining compliance. •Proficiency in CAPA processes and requirements within each phase. •In-depth knowledge of IVD product risk management requirements under ISO 14971. •Demonstrated capacity to write validation protocols and reports. •Basic understanding of statistical techniques and sample size rationale. •Capable of evaluating technical and scientific data and reports to determine their validity. Compensation: •$89,300 - $146,900 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!