Quality Project Manager
Resume:
Arthurene L. Cardwell
Maple Heights, OH 44137
********@*****.***
A seasoned Quality professional with over 25 years of experience in an FDA regulated blood product
manufacturing industry. Over 10 years of management experience. Experience includes hosting regulatory
agency inspections including FDA, AABB, third party audits, and instruction of quality principles.
Skilled leader with an aptitude in developing staff; maximizing workforce potential; building efficiency
into quality operations, problem solving, virtual office management and relationship building.
Manager, Quality 03/2004 – Present
American Red Cross Cleveland, Ohio
Responsibilities:
Responsible for the full scope of quality issues in a region and is accountable for all quality aspects of
regional performance. Lead changes to the regional quality structure to remove internal barriers and
promote cross function/cross training of Quality staff. Quality structure includes the Quality Improvement
Programs, data collection and analysis, Corrective and Preventive Action Program and strategic quality
planning. Direct management of the Quality Department functions (validation, approval of procedures,
internal audits, nonconformance management, statistical sampling strategies. Facilitate, host and
coordinate logistics of FDA Inspections, AABB Assessments and internal/external audits. Perform the
quarterly analysis of customer concerns for investigation and present to upper management for review.
Foster and maintain relationships with operational department heads to achieve regional and national
organization goals including quality / compliance, customer services and financial goals.
National Instructor 9/2012 – 10/2013
American Red Cross Numerous ARC Locations
Responsibilities:
Provide instruction to American Red Cross staff on procedures for the management of Suspect Products in
the new eProgesa software. Traveled to various ARC blood collection/manufacturing locations across the
country training incumbent staff on the new processes to ensure training was delivered consistently within
the organization. During this time of travel maintained current position as Quality Manager remotely
(virtual office) to ensure continuous flow of quality functions.
Quality Assurance 5/1998 - 2/2004
American Red Cross
Responsibilities:
Matriculated through the Quality Assurance career ladder from an entry level Quality Specialist to the
position of Senior Quality Associate. Performed routine and focused Quality System audits; inspected all
incoming labels, printed materials; determined disposition of non conforming products; and coordinated the
performance of routine tasks within the department.
Compliance Specialist / Regulatory Specialist 8/1995 – 5/1998
American Red Cross
Responsibilities:
Perform recalls and market withdrawals of non-conforming products. Assigned donors to deferral
categories for the National Donor Deferral Registry. FDA reporting of biological product deviation reports.
Project manager for local and nationally driven changes.
Laboratory Technician II 6/1988 – 8/1995
American Red Cross
Responsibilities:
Performed routine hematology, chemistry and viral serology testing of daily blood donations. Performed
the primary manufacture of blood products from whole blood. Performed the quarantine of unsuitable
blood products and product labeling for distribution.
Education
1985 Lorain County Community College
AAS - Medical Laboratory Technology
Certifications
MLT - American Society of Clinical Pathologists
Certified Quality Auditor – American Society for Quality
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