Keesha Parker
Senior Quality Assurance Specialist | GMP Manufacturing, CMO Oversight | Building Trust Through Compliance & Continuous Improvement to Ensure Safe, Effective Medicines for Patients
- Role
- Senior Quality Assurance Specialist at Just - Evotec Biologics
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Keesha Parker
Results-driven Quality Assurance Professional with over 15 years of experience in GxP…
Experience
Senior Quality Assurance Specialist
Nov 2022 — Present · 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.
Education
Bates Technical College
Associate's degree
2007 — 2008
Renton Technical College
Certificate of completion.
2004 — 2005
California State University-Dominguez Hills
Master of Science - MS
2021 — 2024
The Evergreen State College
Bachelor's degree
2009 — 2011
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