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director quality assurance resume example with 20+ years of experience

Jessica Claire
  • Montgomery Street, San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
  • H: (555) 432-1000
  • C:
  • resumesample@example.com
  • Date of Birth:
  • India:
  • :
  • single:
  • :
Executive Profile

Quality Manager with over 20 years of experience in a variety of health and medical industries. Recognized for

effectively managing teams, implementing new processes, and reducing defects in highly regulated environments (US FDA, EU). Accomplished in problem solving and skilled in root cause analysis, corrective action planning, and effectiveness monitoring. Demonstrated strong communication skills with staff, management and customers. Demonstrated ability to develop and implement quality processes at a corporate level. Obtained consistent high performance evaluations for work output and management ability. Developed and executed training on leadership, communication, and team building. Coordinated and hosted regulatory and customer audits. Coordinated and executed internal departmental and external vendor audits. Managed and monitored drug study laboratory testing protocols. Managed a team in a high production testing laboratory while maintaining excellent regulatory compliance.

Skill Highlights
  • Project management
  • Leadership/communication skills
  • Strategic Planning
  • Multi Unit Operation Management
  • Quality Management
  • Quality Improvement
  • Budget Forcasts
  • Problem Resolution
Core Accomplishments
  • Managed a team of Quality assurance staff at multiple sites.
  • Hosted all regulatory audits with no major observations.
  • Developed a process for the monitoring of key areas for over 20 plasma donation centers to drive process improvement.which resulted in the reduction in errors was noted.
  • Directed and executed the development and implementation of an automated process to document errors to facilitate problem resolution in a multi-center environment.
  • Directed and facilitated problem solving teams to reduce errors and promote process improvement.
  • Developed and executed training on internal, and external regulatory requirements (GMP, GCP, and EU).
Professional Experience
Director, Quality Assurance, 01/2012 - Current
Kpmg Walnut Creek, CA,
  • Accountable for maintaining the Quality Plan of the organization.
  • Directed all Quality Assurance functions to include the review and release of test results, problem management, validation review, SOP review, and compliance to applicable regulations.
Assistant Director Director, 08/2010 - 01/2012
Carlisle Interconnect Technologies Saint Augustine, FL,
  • Led a team of Batch Release Specialists that perform final review and release of over 1 million samples annually.
  • Reviewed Quality Improvement Reports to ensure proper investigations and actions are performed and documented.
  • Performed final review of validation documents.
  • Hosted regulatory and customer audits.
  • Performed internal and vendor audits.
  • Wrote and reviewed Standard Operating Procedures as needed.
  • Performed quality oversight on any needed area at the Atlanta facility.
  • Was part of the initial team to open the facility acting as the lead of the local quality team.
QA Project Manager (Contract Position), 05/2010 - 08/2010
Redshelf Chicago, IL,
  • Created a process to trend Key Performance Indicators to enhance the compliance to internal and regulatory requirements.
  • Enhanced the processes to identify areas needing improvement and updating the process for continuous improvement.
  • This included the creation and/or revision of SOPs and training as applicable.
Quality Manager, 2009 - 05/2010
Foundation Capital Foster City, CA,
  • Enhanced the compliance to FDA, cGMP, and EU regulatory requirements for the International BioResources Quality Plan by creating the process for monitoring trending reports.
  • This process includes the monitoring of non-conformance reports, donor reactions, machine issues, lookbacks, and test turnaround times using statistical methods.
  • Generated trending reports for organizational review that included a summary of findings.
Corporate Training Manager, 03/2008 - 2009
3M Companies Indianapolis, IN,
  • Helped to develop a new leadership on-boarding process for center management staff.
  • Developed presentations and provided the training on various topics to newly hired company leadership in a classroom setting.
Quality Assurance Auditor, 2006 - 03/2008
Lurie Besikof Lapidus & Company, Llp Fort Myers, FL,
  • Audited the accessioning, testing, and shipping of clinical trial samples to ensure compliance to internal and external requirements.
  • Reviewed and approved non-conformance reports.
  • Reviewed project setup documents to ensure conformance to internal and customer qualifications.
  • Participated and led problem solving teams to improve organizational processes.
Project Manager, 07/2005 - 07/2006
Ascential Chicago, IL,
  • Served as the primary point of contact for the sponsor and interacted with all groups in the coordination of a project.
  • Provided input into project proposals and collaborated on project database designs.
  • Developed communication plans for both the sponsor and the internal team.
  • Led problem solving and resolution.
Senior Associate, 02/2005 - 07/2005
American Red Cross City, STATE,
  • Audited the collection, manufacturing, and shipping of blood for one of the largest Red Cross regions in the United States to ensure compliance to local, state, and federal regulations.
  • Reviewed and approved deviation reports.
  • Led problem solving teams to improve organizational processes.
Sr. Associate, 02/2003 - 02/2004
American Red Cross National Testing Laboratory City, STATE,
  • Monitored problem management process for a laboratory of 90 employees.
  • Suggested strategic plans to senior management to improve testing processes for the laboratory which performed over 100,000 tests per month.
  • Evaluated ongoing corrective actions using statistical tools to ensure proper systems were functioning and meeting in-house, state, and federal regulations.
QC Supervisor/Lead Specialist/Specialist, 05/1996 - 02/2003
American Red Cross National Testing Laboratory City, STATE,
  • Managed a team of six QC employees to include 100% record review of testing and batch release for over 15 thousand tests per day.
  • Supported corporate financial management by scheduling personnel and workflow to efficiently maximize and maintain optimum productivity.
  • Performed human resource leadership by interviewing, selecting and coaching qualified QC Specialists.
  • Led teams to investigate, document, and resolve testing problems and errors.
Education
Bachelor of Science: Biology, Expected in 1991
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State University of New York - Brockport, NY
GPA:
Status -
Skills

Coaching, Continuous Improvement, Senior Management, Financial Management, Leadership, organizational, personnel, presentations, Quality Improvement, Quality Assurance, Strategic Plans, Validation.

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Resume Overview

School Attended

  • State University of New York

Job Titles Held:

  • Director, Quality Assurance
  • Assistant Director Director
  • QA Project Manager (Contract Position)
  • Quality Manager
  • Corporate Training Manager
  • Quality Assurance Auditor
  • Project Manager
  • Senior Associate
  • Sr. Associate
  • QC Supervisor/Lead Specialist/Specialist

Degrees

  • Bachelor of Science

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