Quality Assurance Control
Resume:
PAMELA PRESCOTT
Kennesaw, Georgia 30144
**********@*******.***
Professional Objective: To secure a Senior Quality Assurance position
leveraging my strong leadership and management skills, my expertise in
quality systems development and my passion for mentoring and training
staff.
HIGHLIGHTS OF QUALIFICATIONS
. Quality Systems Manager
. 21 CFR Part 11
. 21 CFR Part 600
. 21 CFR Part 801
. 21 CFR Part 820
. 21 Part 1270/1271
. 29 CFR Part 1910
. CLIA '88
. cGTP
. cGMP
. cGCP
. CMDR/CMDCAS
. Directive 93/42/EEC
. ISO 13845:2003
. Auditing
. Validations
. Corrective Action
. Complaint Handling
. Deviation Handling
. SOPs
. Gap Analysis
. QA Training
. Document Control
. Quality Improvement
. Supervisory/
Management
. Trackwise
. MS Office
RELEVANT EXPERIENCES
. Directed the activities of staff members in blood bank, chemistry,
immunochemistry, hematology, flow cytometry and urinalysis departments to
assure compliance with all relevant industry requirements.
. Provided leadership and guidance to department staff members in the
performance of daily tasks; interacted collaboratively with supervisors
and managers to meet company objectives.
. Assured laboratory operated in accordance with approved SOPs, federal and
local regulations including CLIA, applicable Codes of Federal
Regulations, and other authorities.
. Developed a robust quality management program to meet the Florida Lions
Eye Bank quality objectives, Eye Bank Association of America standards
and the requirements set forth in 21 CFR Part 1271.
. Evaluated, developed and authored policies and procedures that were
consistent with all regulatory and industry requirements.
. Developed technical staff training program and modules in accordance to
regulatory guidelines; assessed proficiency data and reports and
recommended training improvements, as necessary.
. Provided QA training to staff and encouraged error reporting for
continuous improvement strategy.
. Performed gap analysis in preparation for regulatory and standardization
inspections and recommended activities to maintain compliance and
conformity.
. Performed internal and external audits, identified areas for improvement,
approved and implemented corrective action plans.
. Assured staff members met all competencies as required by their job
description and duties; maintained documentation for inspection purposes.
. Developed document control and change control process program to meet FDA
requirements.
. Reviewed device master record and donor history records for release of
products.
. Performed validations of systems to assure that the processes met the
requirements for the intended application.
. Maintained control of the Quality Control program for receiving,
labeling, testing, and acceptance criteria for all incoming reagents or
raw materials.
. Developed safety audit checklist according to OSHA guidelines for the
department safety program.
. Reviewed daily work and quality control documents against established
parameters; performed root-cause investigations and recommended
corrective actions/preventive actions.
. Collected, evaluated, and maintained data to assure compliance with
regulatory requirements and for trend analysis.
. Assured that the disposition of all products was appropriately controlled
so as to limit the potential for mix-ups.
. Maintained the tracking of over 100,000 tissue products and assured the
traceability of the tissue from the donor to the surgical center.
. Assured that all products placed on hold were appropriately evaluated;
assured all activities that were relevant to the disposition of the
product were documented in the device history record.
. Assured the timely response to customer complaints, reviewed and approved
all follow-up actions
. Assured that all equipment was maintained according to manufacturer's
instructions; assured all laboratory equipment was suitable for use
through validation protocols.
. Composed managerial reports using financial, quality, and personnel data;
managed department budget.
CERTIFICATIONS:
Certified Quality Auditor, ASQ, 2008
Quality Improvement Associate, ASQ, 2006
Medical Laboratory Technician, ASCP, 1997
CONTINUING EDUCATION:
Six Sigma Black Belt, Currently Enrolled
CMDR and CMDCAS Training, Georgia, August 2010
Communicating for Results, Florida, January 2008
Six Sigma Introduction Course, Virginia, March 2004
Equal Opportunity Representative Course, Washington DC, June 2000
Supervisor Development Course, Virginia, April 2000
Leadership and Education Development Course, Washington DC, December 1998
The Small Group Instructor Course, Washington DC, January 1998
EDUCATION:
M.S., Quality Assurance, California State University, pending Fall 2011
graduation
B.S., Management Studies, University of Maryland University College,
December 2003
Project Management Certificate, University of Maryland University College,
August 2003
Medical Laboratory Specialist, Medical Laboratory Specialist Advanced
Course (311-92B30),
U.S. Army, May 1988
POSITIONS:
2011 - 2011 Quality Assurance Associate, Contractor
Corporate Search International, Georgia
2010 - 2011 Quality Assurance Associate, Contractor
Advanced Recruiting Partners, Georgia
2009 - 2009 Quality Assurance/Quality Control Manager
Octapharma Plasma, Inc., Georgia
2008 - 2009 Quality Control Manager, Quality Control
ImmucorGamma, Inc., Georgia
2005 - 2008 Quality Assurance, Director
Florida Lions Eye Bank, Florida
2002 - 2004 Supervisor, Clinical Pathology
U.S. Army, D.D. Eisenhower Medical Center, Georgia
2000 - 2002 Supervisor, Transfusion Services-Core Laboratory
U.S. Army, Walter Reed Medical Center, Washington DC
1995 - 2000 Supervisor, Clinical Laboratory
U.S. Army, Andrew Rader Health Clinic, Virginia
1992 - 1995 Quality Assurance Coordinator
U.S. Army Europe Blood Donor Center, Germany
PROFESSIONAL ORGANIZATIONS:
ASQ, Senior Member
ISPE, Student Member
VOLUNTEERING ACTIVITIES:
American Red Cross Blood Drive Liaison, Woodstock Christian Church, Georgia
September 2010 to Present
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