PamelaJoyce Jones

Highly focused Quality Assurance Professional with experience managing, prioritizing, and supporting requests for compliant guidance and oversight. A leader within the Quality Assurance department, providing risk based decisions and justifications that comply with regulatory agencies, Good Manufacturing Practices (GMPs,) Good Laboratory Practices (GLPs), and Code of Federal Regulations (CFRs). Comprehensive understanding of navigating United States Pharmacopeia, European Pharmacopoeia and Japanese Pharmacopeia guidelines. Recognized for complex problem solving, compliance intelligence, attention to detail, results delivery and driving improvements. Experience interfacing with corporate, federal, and international inspectors. Proven success working with change control systems, deviation investigations, root cause analysis, and corrective and preventive actions (CAPA). Highly effective at coaching and mentoring, resulting in the cultivation of healthy cultural dynamics and increasing individual contributors engagment and performance. AREAS OF EXPERTISE: Compliance Document Review Analytical Data Review Technical Writing Molecular Biology Cellular Biology Immunochemistry TECHNICAL COMPETENCIES: Cellular and Molecular Biology Techniques: RT/PCR, Western Blot, Enzyme Immunoassay, SDS-PAGE, Recombinant protein production, purification, and quantitation, Protein concentration determination by UV absorbance Risk Mitigation: Quality Assurance, Quality Control, Lean/Six Sigma Informatics: Document Management Systems, Laboratory Information Management System (LIMS), Consumable Inventory Management System (CIMS), Systems Application and Products (SAP), Calibration and Software Asset Management (ProCal) V5, TrackWise Compliance Management System.