Keesha Parker

Senior Quality Assurance Specialist @Just - Evotec Biologics

Redmond, WA, US

Directed QA oversight of deviations, CAPAs, and change controls, including triage, investigation, review, and closure, ensuring effective root cause analysis and sustainable corrective actions. Developed and implemented deviation management tools, including a paper-based system for business continuity and targeted checklists for root cause investigations.•Partnered with SMEs to lead contamination-related investigations, implement CAPAs, and strengthen root cause and risk mitigation strategies for sterility assurance.•Monitored and reported Quality System performance, managing KPIs within the eQMS, analyzing trends, and presenting insights and recommendations to senior leadership.•Provided QA oversight for risk assessments, SOP development/revisions, and initiation of eQMS records in response to functional area notifications.•Supported compliance through internal and client audits, ensuring readiness and seamless execution of audit activities.•Executed and supported GxP training programs, identifying learning needs, coordinating with stakeholders, and delivering effective training to strengthen compliance.•Trained staff on deviation management, investigation techniques, and technical writing, improving consistency and quality of QMS records.

Bates Technical College

Associate's degree

Renton Technical College

Certificate of completion.

California State University-Dominguez Hills

Master of Science - MS

The Evergreen State College

Bachelor's degree