Quality Assurance Medical Device
Resume:
NORMAN A. LEWIS
Detroit, Michigan 48235
(248) 219- 5736 (Cell)
Email Address: ******@*****.***
PROFESSIONAL
Perform quality assurance internal and external audits for pharmaceutical, clinical trial, medical device and dietary supplement manufacturers to ensure the integrity and regulatory compliance of products or services.
QUALIFICATIONS / EXPERIENCE
Quality Assurance Auditor IRCA ISO 9000 Auditor Certification, Statistics, Microsoft Word, Access, Excel, Teammate, FDA 483, Response Letters, Facilitated FDA/Regulatory Agency inspections, Consent Decree/Compliance Audits, Developed System Audits, Customer Complaint Resolution, Laboratory Record Review, Corrective Action Implementation, Investigation of Deviations, Tracking and Trending, Error and Accident Reports, Review of Non-Conforming Materiel, Supplier Quality Audits, Equipment / Process Validation, Q7A Active Ingredient Audits, Finished Pharmaceutical Audits, Good Clinical Laboratory Practices, Blood Regulations and Audits of Facilities, Audits of Contract Research Organizations, ICH Regulations, GLP Review, Clinical Trial Audits, and COSO based Internal Risk Analysis
EMPLOYMENT
American Red Cross National Headquarters
Washington, D.C. • July 2011 to December 2011
Senior Internal Biomedical Auditor
Responsibilities primarily involve reviewing and performing biomedical internal auditing projects that pertain to operational, financial, and regulatory compliance departments. Fieldwork engagements for the American Red Cross include the 5 National Testing Laboratories, 7 Divisions and 36 Regional facilities. The audit work and field work related to the identification of operational risks, internal controls, testing for controls in moderately to highly complex operations with some integrated components and the test work documentation of such activities by developing; process documentation, scope matrices, risk analysis, and audit programs. Compiled Internal Biomedical Audit Reports that were directly received by the Board of Governors of the American Red Cross.
Sun Pharmaceutical Industries Inc. and Caraco Pharmaceutical Laboratories (subsidiary of Sun Pharmaceutical) - Detroit, Michigan • 2006 to 2011
Manager of Supplier Compliance for North and South America
Responsibilities include identifying areas or departments in solid dose manufacturing that are out of compliance with FDA regulations, monitoring compliance activities, tracking and trending observations, and reviewing corrective/ preventive actions. External audits are performed for Caraco and Sun Pharmaceuticals of India, Sun Pharmaceuticals of Cranbury, New Jersey and Bryan, Ohio. External audits are performed domestic and internationally at active pharmaceutical ingredient manufacturers, excipient manufacturers, dietary supplement manufacturers, contract research organizations, clinical and non-clinical research facilities, packaging operations, and pharmaceutical finished product manufacturing facilities.
Stiefel Laboratories – U.S. Manufacturing Facility • Oak Hill, New York • 2005 to 2007
Manager, Quality Assurance External Auditing for North and South America
Performed audits of Active Pharmaceutical Ingredient suppliers, finished product suppliers, components suppliers, clinical testing facilities and contract testing in North and South America at a rate of 2-4 audits per month. Responsible for organizing and disseminating detailed objective audit reports that are used to make procurement decisions, concerning all classes of dermatological and topical pharmaceutical products. Also responsible for auditing clinical, non-clinical research facilities, dietary supplement and medical device manufacturers as needed.
Oak Park School District – Oak Park, Michigan • 2003 to 2004
High School Biology/ Chemistry Teacher and District Substitute Teacher
Responsible for the science education and safety of 9th through 12th grade high school students. Developed detailed lesson plans for the teaching of biology and chemistry, conducted biological and chemical experiments based upon various methods of learning and supervised scientific field trips to emphasize classroom learning.
American Red Cross - National Headquarters • Rosslyn, Virginia • 1998 to 2002
Quality Assurance and Regulatory Assessments, Quality Auditor II
Conducts world wide independent quality and regulatory assessment audits of American Red Cross Regional, National
Testing Laboratories, Computer Development Centers, National Headquarters, and assorted suppliers to monitor, assess
and report the effectiveness of applied standards. Results are used to identify areas needing improvement and also assist
management in preventing errors and improving quality of blood products.
American Red Cross - National Testing Laboratory • Detroit, Michigan • 1995 to 1998
Quality Assurance Specialist
Facilitated FDA, ARC-QRA, AABB, CLIA, and other regulatory agency inspections. Analyzed data and identified trends
associated with, but not limited to laboratory testing, proficiency testing, QC, equipment / supplies / reagent defects.
Generates System Audit Reports, Error and Accident Reports, Laboratory Record Review Audits, to be forwarded to the
Quality Assurance Officer or National Headquarters of Biomedical Services.
American Red Cross - National Testing Laboratory • Detroit, Michigan • 1994 to 1995
Reagent Control Specialist
Inspected 100% of incoming laboratory reagents and supplies for non-conformity. Maintained all records and logs for
receipt of reagents and supplies. Also responsible for reviewing package inserts for changes or modifications to testing
procedures that could adversely affect blood manufacturing.
EDUCATION
Northwestern California University School of Law
Presently attending law school (2015 graduation date)
Wayne State University, Detroit, MI
Molecular Biology – graduate courses (2002-2004)
Northern Michigan University, Marquette, Michigan
B.S. Physiology / Chemistry
PROFESSIONAL MEMBERSHIPS
American Society for Quality (ASQ)
Institute of Internal Auditors (IIA)
International Register of Certificated Auditors (IRCA - ISO 9000)
Regulatory Affairs Professional Society (RAPS)
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