Kristen N. Email & Phone Number

Durham, North Carolina, Us

Bothell, Wa, Us

Fort Collins, Co, Us

Lawrence Township, Nj, Us

Summit, New Jersey, Us

Spokane, Wa, Us

Highly motivated professional with progressive expertise in Quality Assurance and Quality Control initiatives. Drive continuous improvement to advance quality and enhance operations. Ensure consistent compliance with ISO standards, quality assurance protocols, and company requirements. Exceptional technical aptitude and analytical strengths; demonstrated expertise troubleshooting issues and offering solutions to boost quality. Articulate communicator and quick to build positive relationships at all levels. HIGHLIGHTS OF EXPERTISE• Quality Assurance / Control• Good Laboratory Practices (GLPs)• Technical Documentation• Continuous Improvement• Standard Operating Practices (SOPs)• Workflow Optimization• Mentoring / Training• Team Building & Leadership

Spokane, Wa, Us

Orchestrate laboratory activities across multiple production/controlled environments, ensuring all ISO-classified areas receive proper coverage for Quality Assurance (QA) and sampling/testing functions are performed in accordance with SOPs, CAPAs, and MWO. Delegate daily tasks, monitor jobs, and document all issues; verify all needed supplies are within the laboratory. Generate detailed technical documents, including incidents, alerts, actions, CAPAs, SOPs, and memos. Collaborate with all supporting departments to ensure resolution to production line issues in alignment with quality protocols. Utilize analytical data to review lab results for accuracy and compliance with SOPs; review EtQ (Quality and Compliance Management System). Supervise team of 6 EM Technicians. Provide hands-on training/support; address inquiries and ensure smooth operations. • Played key role during major restructure; led successful reclassification of all ISO rooms within a 4-month period.• Built a highly efficient team within the Environmental Monitoring department; delivered training on equipment operations and lab compliance in relation to Good Manufacturing Practices (GMPs), Standard Operating Practices (SOPs), and safety protocols. • Facilitated QA/QC compliance specifically related to manufacturing; monitored environment of manufacturing area, created samples in SAP, and generated SOPs in order to provide comprehensive training.• Drove workflow optimization through hands-on leadership; selected key personnel as Subject Matter Experts to assist other team members, contributing to success of department.• Effectively relayed complex technical terms in an easily understood manner, thereby facilitating comprehension of technical language within SOPs. • Instrumental in reducing error ratios; commended by senior management for quality job performance.