Eddie S. Simmons

CQIA

**** ****** ***** / ********, ******* 30058

ac5t9a@r.postjobfree.com

678-***-****

SUMMARY OF QUALIFICATIONS

Accomplished Quality Assurance professional with over 20 years of Quality Assurance and Manufacturing process improvement expertise in the Blood, Consumer Products & Medical Device industry. Proven leadership skills with the ability to leverage exceptional interpersonal skills, flexibility and teamwork to achieve business objectives. Effective oral and written communication. Outstanding problem solving skills with additional strengths in the following areas:

Quality Systems Management

Training

Coaching / Mentoring

Supplier Quality/Relationship Management

Facilitation

ISO/Supplier Quality Auditing

PROFESSIONAL EXPERIENCE

American Red Cross June 2010 – December 2018

Douglasville, Georgia

Quality Assurance Officer

Coordinate Manufacturing QA personnel across 5 regions for Quality Improvement and standardization activities. Implementation of the ePROGESA electronic tracking system for blood manufacturing. Conduct Quality Workshops with manufacturing personnel. Perform Quality Walk-through of manufacturing departments to maintain compliance to Regulatory Agencies. Write reports for Sr. Management on status of Quality Systems throughout 5 manufacturing facilities.

Achieved a 40% reduction in compliance problems through the use of group discussions with staff and management.

Improved the compliance profile by 30% for the Douglasville manufacturing site through the use of process mapping, effective corrective action and utilizing employee input for process improvement.

Achieved a 25% reduction in shipping errors to hospitals by observing staff performing the process and holding departmental meetings with staff resulting in procedural changes.

Lead teams on standardization projects within the Quality System.

Provided the QA function for the Plasma Sort Facility.

Life Therapeutics January 2009 – August 2009

Clarkston, Georgia

Quality Assurance Specialist (Contract position)

Deploy the QA function throughout the manufacturing process, Final Product review/release, NCR management, CAPA system management, Internal Audit, DHR Review, Incoming Materials Approval, QA of validation studies and protocols, ISO audits, Supplier Management, Line Clearance

Implemented a Supplier Management system in compliance with CFR 21 800 and ISO 13485 requirements.

Coordinated QA corrective actions for ISO audit findings.

Reduced closure of NCR/CAPA cases from 2 months to 3 weeks by forming weekly compliance meetings between departments so that there was management awareness and updating of the status of cases.

Chemtura/BioLab Division January 2000 – May 2008

Lawrenceville, Georgia

Supplier Quality Leader (2005-2008)

Create/Manage Supplier Quality System, Support Quality/Cost Reduction Initiatives, Develop Supplier Qualification Database, Manage CAR Database, Manage RCA for Supplier based issues, Manufacturing ISO Representative, Technology Transfer, Training, Quality Audit

Quality system set-up and audit of domestic & overseas Suppliers (contract and internal).

Supported Production process improvement initiatives and Lean concept implementation increasing overall efficiency.

Supervised qualification activities for existing and prospective Suppliers decreasing qualification time from 2 months to 3 weeks.

Team Leader for ISO Qualification effort coordinating associated departments for ISO compliance.

Reduced Supplier –based complaints by 50%.

Performed corporate training on: GLP, ISO9000, GMP, Supplier Quality Database and RCA.

Coordination of investigation and closure of customer based complaints.

Quality Assurance Unit Manager for GLP Program / Raw Materials Specialist (2000-2004)

Manage entire Good Laboratory Practices program, Evaluate and approve Contract Laboratories. Qualify all new and existing Raw Materials, Manage Quality System for Toll Manufacturers, Divisional ISO Auditor

Responsible for Document Control, Study Audit, Archive Management and final Quality Approval for GLP Studies that were submitted to the EPA

Led two consecutive successful Audits by the EPA

Coordinated Raw Material Qualifications

Lead Auditor for internal ISO Audits of Corporate facilities

Coordinated and led qualification activities for toll manufacturing facilities

Ciba Vision Corporation November 1987 – April 1999

Atlanta, Georgia

Test Lab Manager/Technical Projects (1994-1999)

Laboratory Management, Lab Equipment Evaluation and Validation, Technology Transfer

Process Mapping, Budget Development and Maintenance, Toll Manufacturer laboratory development and set-up,

Management of 16 technicians and scientists over 3 shift operation.

Supervised set-up of Malaysian Quality Laboratory within a 6 month time frame.

Team Leader for headquarters Q.C. Laboratory ISO certification.

Quality Representative for new and existing manufacturing projects including IBM based Continuous Flow Manufacturing Initiative that made manufacturing more efficient.

Quality Laboratory Representative for FDA Audits.

Reduction of sterilization release time from 84 hours to 24 hours saving 220K per year.

Stability Affairs Scientist/Research Scientist-R&D (1987-1993)

Polymer research and development, Technology Transfer, Process Development, Preparation of Stability Reports for FDA Submissions

Performed developmental studies on new and existing polymers thus enhancing product line.

Development of Microwave lens tinting process which increased production capability by 30%.

Leader of “clean room” air quality monitoring project meeting FDA compliance requirements.

Performed Stability studies and composed submission reports for new and existing lens products.

EDUCATION

Morehouse College

Major-Biology/ Minor Chemistry

TRAINING

ASQ Certified Quality Improvement Associate

ISO Lead Auditor GMP Training

GLP Training Quality through Defect Prevention

IBM Continuous Flow Manufacturing Quality Auditing (ASQ)

Quality Assurance in Analytical Chemistry (ACS) Supplier Quality Audit

Technical Writing

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