Thomas Sackett Email & Phone Number

Established Quality Professional with over 25+ years of experience working within the Medical Device, Biomaterial, and Pharmaceutical industries in various increasing roles in leadership and quality management, regulatory compliance, manufacturing and service operations, process improvement, and electronic system integration. Highly versed in 21 CFR Part 820, ISO 13845, ISO 14971, ISO 9001, ISO 17025, EU MDR 2017/745, GMPs and GLPs (FDA 21 CFR Parts 210 & 211) with emphasis on Quality Assurance and Manufacturing requirements. Fully competent in all matters of QSR; CAPA, Complaints, Change Control, NCMR, Risk Management, Documentation Management, Constant Continuous Improvement, and Internal and External Auditing.ASQ Certified CMQ\OE (Quality Manager), CMDA (Medical Device Auditor), CQA (Quality Auditor) Routinely accomplish annual ISO recertifications and FDA inspections; including the successful process transfer for two PMA products, routine QSIT, and various manufacturing scope expansions to include design controls, analytical methodologies, and sterile filling qualifications.Provide leadership in Quality on departmental and cross-functional initiatives by applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues. Utilizing tools such as FMEA’s, DMAIC, Root Cause Analysis and Risk Assessment procedures. Robust understanding of operational functions including manufacturing, logistics, and contract services. Proficient in a wide array of aseptic processes; clean rooms, isolators, autoclaves, clean steam generators, SIP, CIP, dry heat sterilization, gamma, EtO, E-beam, and micron filtration. Facility knowledge and management of HVAC systems, USP and WFI water systems, heat exchangers, coolers, cryogenic freezers, environmental chambers, etc.Extensive background in analytical chemistry, instrumentation, and method development, transfer, and validation including the implementation of data acquisition systems, EDMS, LIMS, and 21 CFR Part 11 compliance.

Listed skills include Quality System, Management, Leadership, Analytical Chemistry, and 42 others.

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  Saint Joseph'S University

  Chemistry