Quality System Compliance Consultant
Highly motivated, results driven, Quality System Compliance Consultant who has the technical knowledge, industry experience, and outstanding interpersonal skills needed to work with clients to develop effective quality system solutions.
Summary of Qualifications
Fifteen years experience in FDA regulated industries including biologics, drugs, medical devices, and dietary supplements. Exceptional communication and interpersonal skills including the ability to interact comfortably and professionally with new and established clients, individuals at all levels of an organization, and regulatory representatives. Proven ability to lead successful Quality organizations in Quality Control, Quality Assurance, Quality Operations, and Manufacturing settings. Skilled at translating technical and regulatory knowledge into effective and engaging instructor lead and web-based courses based on sound adult learning theory. Experienced working remotely and independently as a consultant: designing quality systems, preparing regulatory documentation such as SOPs, DMFs, regulatory responses, and validation protocols; performing facility audits; and preparing and delivering course content during public seminars, customer training sessions, and college course content. Skilled at using Articulate Presenter, Engage, and Quizmaker rapid e-learning software and e-learning authoring tools to create excellent web-based training.
Professional Experience
AUK Technical Services
Quality System Expert – October 2003 – Present
Successfully redesigned the CAPA system for a major vaccine manufacturer and participated in the global rollout of the new system. Assisted in the consent decree related remediation efforts at one of the largest producers of over-the-counter (OTC) medicines. Developed and delivered course content for instructor-led seminars in CAPA, process validation, audit management, documenting investigations, and quality system regulations. Created CAPA and design control systems for one of the world’s leading distributors of rehabilitation supplies and assistive patient products.
Validation and Compliance Institute Trenton, Michigan
Contract Quality System Consultant – October 2003 – September 2009
Created course content and delivered course lectures at the University of Michigan as part of ChE 696 Quality Systems for Medical Manufacturing. nufacturers. Created 21 CFR 111 Dietary Supplement cGMP training material and delivered training presentations for NSF International. Drug Master Files. Developed and delivered course content for public seminars and on-site customer training sessions for courses in validation, CAPA and microbiological control. Designed web-based courses using Articulate Studio e-learning software.
Baxter BioScience, Rochester, Michigan
Quality Operations Manager – July 2000 – September 2003
Developed the first Quality Operations Department within the Rochester facility. Led the effort to drive a 25% reduction in manufacturing nonconformances. Wrote, reviewed, and approved manufacturing related cleaning, equipment, and process validation protocols. Directed activities related to failure investigations, root cause analysis, customer complaints, manufacturing process audits, in-process batch record review, in-process component release, improvement efforts with respect to quality, product yields, variation reduction, and process velocity, development and revision of standard operating procedures and identification and implementation of “Best Demonstrated Practices”. Prepared and presented training material for classes that focused on: building productive relationships between the quality and manufacturing departments, bioburden reduction, general microbiology, 21 CFR 211, 21 CFR 600, and various FDA guidance documents.
Quality Control Microbiology Supervisor – October 1998 – June 2000
Selected as a member of the team responsible for developing the division environmental monitoring procedure. Responsible for the development, implementation, and maintenance of the Quality Control, Microbiology testing program. Directed all activities related to microbiological monitoring of critical utilities, facilities, and personnel within aseptic filling and plasma Fractionation operations. Developed a relationship between the Manufacturing and Quality departments which facilitated successful resolution of quality related issues. Created training material used to educate the manufacturing staff on cGMPs and general microbiological principles.
Microbiology Laboratory Technician – January 1998 – October 1998
Performed sterility testing on all final container products. Wrote standard operating procedures. Performed in-process product bioburden testing.
Lab Support, Southfield, Michigan
Microbiology Laboratory Technician – May 1997 – December 1997
Education
Bachelor of Science in Biology, Specialization in Microbiology
Oakland University, Rochester, Michigan
April 1997