Gretchen Mcauliffe Email & Phone Number

• Professional Quality Consultant with 18 years experience in diverse business sectors including FDA regulated industries (food, petrochemical, specialty chemical, pharmaceutical excipients, semiconductor, medical device, biotech, general manufacturing).• Certified Auditor with background in ISO 9001 (RABQSA certified lead auditor), ISO 13485, ISO 17025, Good Manufacturing Practices (GMP), Good Laboratory Practices (RQAP-GLP certified), and IPEC:PQG pharmaceutical excipient guidelines. American Society for Quality Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), Certified HAACP Auditor (CHA), Certified Pharmaceutical GMP Professional (CPGMP). • Technical Writer experienced in business system process mapping, document management, standard operating procedures, forms & templates, quality manuals, validation documentation and regulatory submission documents. Has written documents across the business enterprise (quality, regulatory, operations, maintenance, purchasing, logistics).• Regulatory Specialist with experience in GMP and GLP environments. Managed GMP laboratory, stability programs, customer complaints, audits, OOS investigations, batch record review and product release. Knowledgeable in analytical, process, and software validation and qualification of equipment.• Project Manager for quality systems deployment, quality database design and deployment, Salesforce, LIMS implementations, employee training program design, statistics based improvement projects (SPC, six sigma), regulatory submissions, validations, Trackwise®, root cause analysis, and laboratory systems such as calibration, maintenance, safety,Specialties: Quality System ImplementationProcess Efficiency & ImprovementFDA GMP Regulated EnvironmentsExcipients (IPEC)AuditingTechnical WritingQuality AssuranceStatistical Process ControlRegulatory ComplianceLaboratory Systems

Listed skills include Research, Microsoft Word, Microsoft Office, Quality System, and 23 others.