Quality Assurance Technical Specialist with extensive experience conducting QA compliance, and technical review and approval of engineering qualification documentation related to new and existing process equipment, utilities, automation systems, and stability protocols for operational readiness. Additional experience conducting production batch and formulation records for clinical and commercial client manufacturing to ensure current regulatory requirements and industry practices are in compliance with specifications and procedures. Participate in FDA, EMEA, and various external audits and inspections, and assist in audit findings resolutionsCore Competencies |Specialties:• Lean Six Sigma Yellow Belt• QA technical compliance review in CGMP areas• External and internal audits• Deviations and CAPA• Production batch records• Validation and system lifecycle protocols • Change management• TrackWise application• Kneat application• Master Control application• Cleaning validation