Highly motivated professional with a proven record of accomplishments and
achievement that can bring forth a combination of analytical expertise and
leadership skills to the workplace.
CAREER EXPERIENCE:
Abbott Diabetes Care (ADC), Investigation Progressor 10/2006-Present
Progresses investigations and ensures that ERs, and CAPAs meet required
standards and procedural requirements.
Supporting projects, activities and BOM change process and activities
in the Sustaining Engineering team to ensure that processes and methods
implemented comply with the necessary Quality and Regulatory requirements.
Management and review of project activities and procedures. Ensures
actions are on time, in full and cost effective to meet the needs of the business
and customers, and that they support core values of the division.
Developed electronic management system to ensure all ER related
documentation is managed in a controlled location.
Developed internal metrics to provide management trends of volume of
work in the systems to be understood and prioritized.
Abbott Diabetes Care (ADC), Quality Assurance Engineer 5/2005-10/2006
Review of documentation for accuracy, clarity, consistency,
completeness and compliance. Project efforts include review of System
Specifications/Requirements documents, Validation protocols, Trace Matrices and
Validation Summary Reports to maintain the effectiveness of the quality system.
Maintenance of 21 CFR Part 11 Program at ADC. Developed Excel
spreadsheet containing ADC Software in use, as well as validation and compliance
information. Developed the Quality System and 21 CFR Part 11 compliance forms to
assist internal customers in defining applications that are within the Quality
System.
Developed Matrix for internal customers providing an overview of the
relationship between non-product procedures, processes and templates of
non-product software lifecycle.
American Red Cross, Project Coordinator 1/2003-11/2004
Project Coordination for the Implementation/Support for Maximo software
through all Regions.
Supported activities related to validation processes, and equipment
used in manual and automated blood collection, component production, donor
suitability, labeling, quarantine, and quality control.
Supported Validation Master Plan process to ensure all facilities meet
the validation requirements.
Provided guidance for facility staff and QA staff to ensure ARC
facilities meet targeted deadlines.
Developed Electronic library consisting of validation plans, equipment
manuals of over 15,000 pieces of equipment (Microsoft Access Based).
A4T, Project Manager 2001-2003
Development of Program’s policies, procedures, objectives, and
initiatives in the administration of grants and funding.
Research and development of programs in maintaining organizations
competitive position through presentations and written materials to various
audiences. Some audience includes: Secretary of State, USAID, United Nations,
World Bank, Voice of America, NPR.
Development of a web-enabled knowledge database used internally by
internal employees and external clients. Database was eventually outsourced to
the Bearing Group for internally market clients.
American Red Cross, Business Planning Analyst 2000-2001
Developed business plans for market trend of new products and
technologies developed internally.
Provided marketing and financial analysis on competitive products.
Coordinated, compiled, and analyzed technical data regarding trends,
existing and potential customers, competition, and technology threats.
Marketing analysis reports generated and presented on a variety of
diseases, therapeutic areas, and markets.
Managed external contractors who conducted primary marketing research
studies for department.
Consulted with scientists and marketing staff for input on market
planning and project evaluations.
Assessed commercial value and financial soundness of new proposals from
the research department.
Planned advisory committees and task forces, internal and external to
the Red Cross, which addressed issues, related to product development
activities.
American Medical Student Association, Project Manager 1999-2000
Managed computerized longitudinal tracking and evaluation system for
the National Health Service Corps Health Promotion/Disease Prevention project.
Coordinated project tasks, reports, and expenses for Federal contract.
Database administration included systems-design, configuration of
database servers, user management, and support.
Provided technical guidance to development staff, as well as outside
vendors.
Conducted periodic meetings with external committees marketing programs
resources to be used in its fullest potential.
United States Geological Survey, LIMS Database Administrator 1999
Administered Access based Laboratory Information Management System
(LIMS), an integrated database comprising pertinent safety, facility, and
personal training management information.
Managed chemical inventories on a per lab basis and lab specific
Chemical Hygiene Plans.
Designed specific lab emergency response procedures, National Center
Occupant Emergency Plans, operation specific Job Hazard Analysis and SOPs.
Defined and classified specific operations; characterized appropriate
laboratory space, incorporated a numerical laboratory hazard classification
scheme and enhance laboratory renovation planning and construction efforts at
National Center.
Linked with the Management Information System to manage
employee-training records, inclusive of tracking and tickler capability, that was
linked to the USGS space management and locator systems.
Integrated and maintained the Computer Aided Design (CAD) floor plans
for the National Center, and Eastern Regions Field Centers into Aperture.
EDUCATION:
Masters in Business Administration, Strayer University, Alexandria, VA 1998
Bachelors of Science, Biology, Marymount University, Arlington, VA 1997
References are available upon request.
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