Marshall Thompson Asq Cpgp Email & Phone Number

Wilmington, NC, US

• Multiple audits conducted as lead auditor or team member on pharmaceutical, medical device and combination products.
• Coach/Mentor for production and quality personnel on cGMPs for a solid dose drug manufacturer.
• Consultant for a sterile ophthalmic solution manufacturer on a data integrity project.
• Consultant for investigations for a sterile ophthalmic solution manufacturer.
• Consultant for a solid dose drug manufacturer for a Quality Systems Remediation project.
• Consultant for a solid dose drug manufacturer for a batch record and CAPA verification project.

Wilmington, North Carolina Area

• Facilitating FDA, external and internal audits, acting as the key interface point for auditors, documenting responses and corrective actions to audit findings.
• Manager for submission, investigation, tracking and resolution of all CAPA’s, Change Controls, Deviations and Non-Compliances. This included being the liaison to suppliers for incoming quality.
• Trained, mentored and coached QA Inspectors in proper procedures and documentation of product inspections in all phases of pharmaceutical manufacturing.
• Trainer for 1,200 plant employees on cGMP Regulations, OSHA/Safety, and SOPs (Standard Operating Procedures).
• Project Lead for the selection, verification, validation and implementation of Master Control (software application for electronic document control and training management). Also System Administrator and Trainer for.
• Responsible for Document Control of all Quality Records and the review/approval of all SOPs. Author of multiple SOPs.

Wilmington, North Carolina Area

• Responsible for compliance with the Accreditation Commission for Health Care Standards.
• Managed over 500 client’s Medical Records, responsibile for compliance with HIPAA regulations.
• Created all documents and document control system for all necessary government documents for a DME (Durable Medical Equipment) Supplier.

Newark, DE

• Working Manager for eight technicians.
• Responsible for verification and validation of all Hologic products.
• System Change Control Board Leader - led a cross functional team to adjudicate all Change Requests for Hologic products and determine any Regulatory impact.
• System Change Database Administrator – Project Lead for selection and implementation of system. Wrote and executed verification and validation test scripts.
• Software Release Manager - ensured all software complied with applicable regulatory requirements.
• Responsible for Document Control of all Quality Records and the review/approval of all SOPs. Author of multiple SOPs.

Newark, DE

• Responsible for the verification and validation of the Linx Networking System, a Qnx 4 based diagnostic imaging management system.
• System Change Control Board Leader - led a cross functional team to adjudicate all Change Requests for Sterling products and determine any Regulatory impact.
• Project Lead for the design and implementation of the System Change Database. Wrote and executed verification and validation test scripts.
• Leader of the R&D Internal Audit Program with responsibility to schedule and conduct all internal audits.
• Responsible for Document Control of all Quality Records and the review/approval of all SOPs. Author of multiple SOPs.
• Manager for submission, investigation, tracking, and resolution of all CAPA’s, Change Controls, Deviations, and Non-Compliances.

Newark, DE

• Responsible for achieving the initial ISO Certification for the Equipment, Service and Support organization in 1993.
• Planned, wrote and implemented the work procedures for the entire Customer Support Center (CSC) which included Instrument and Chemistry Call Specialists, Incoming Call Handlers and Regional Call Managers.
• Training coordinator for the entire CSC on Medical Device Quality System Regulations and over 300 work procedures.
• Qualified internal auditor who served as lead auditor for audits of the World Parts Center, Manufacturing, R&D, Marketing & Technical Support, and Regional Field Offices.
• Key member of a team which implemented a company-wide complaint handling system to expedite the review, research and reporting of customer complaints.
• Primary Instrument Call Specialist responsible for queue management and assisting other call specialists. Maintained a 95% fix rate while having the highest call volume of all Call Specialists.

Norfolk, Virginia Area

• Served on 2 destroyers with duties including operation, maintenance, and repair of the sonar equipment.
• Responsible for the 3M System, the Navy’s tool to document maintenance and corrective action for the equipment.

Sonar Technician

Education record