Quality Control

LeShawn DimeryLeShawn DimeryLeShawn Dimery

**** ****** **** ***** *********, NC 28216 Home 704-***-**** Cell 704-***-**** E Mail: *********@******.***

Objective

To obtain a position where I can maximize my quality assurance, leadership and organizational skills. Over 15 years of experience

within an FDA regulated industry with an emphasis on Quality Systems, CAPA, Complaint handling, investigations/deviation

management, root cause analysis and document control ensuring cGMP Compliance.

Experience

Validant Consulting – Post Market Clinical Investigation Consultant October 2013 – February 2014

Fresenius Medical Care North America

Ensured System level complaints were robust and managed in a uniform and timely manner for equipment and drug products.

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Worked closely with medical device users to understand issues and ensure adequate resolutions.

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Final approver of complaint files for closure in a consistent manner utilizing pertinent information.

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Participated in SOP revisions/creation to maintain regulatory procedures and policies for ongoing compliance and new products.

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Lead cross team process improvements, resulting in a simple and sustainable complaint process.

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Provided leadership and guidance for effective and timely communication and appropriate escalation of product quality issues to

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all levels of the organization.

Implemented and monitored CAPA activities internally and externally.

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Coordinated systematic collection of internal and external data on product safety and performance to support complaint file

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investigations and closures.

Collaborated with technical and/or clinical peers in cross functional groups to ensure a thorough product analysis. Processed

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results and formulated a reasonable conclusion for the reported issue.

Maetrics LLC – Senior Compliance and Quality Consultant April 2013 – October 2013

Johnson and Johnson Dupuy Synthes

Responsible for the management of complaint handling, MDR and Post Marketing Surveillance activities along with non

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conformance investigations, field actions, documentation control and metrics for Class II and III medical devices.

Accountable for the oversight and direct support of technical evaluations and investigational tasks required for complaint

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processing/closure including analysis of CAPA activities.

Directly interfaced with hospitals, surgeons and engineers to determine the report ability of product complaints for adverse events

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and other functional areas as required to ensure clear understanding/investigation of applicable issues.

Participated in weekly meetings as well as generated reports on the status of complaints to ensure deadlines were met along with

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the status of CAPA management.

Processed and closed complaints in a timely manner as well as reporting MDR’s to the FDA utilizing ETQ.

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Provided guidance to peers as well as involvement in the field action and complaint handling process.

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Maintained knowledge of ISO13485, CFR, MDD and QSR.

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Direct ownership of CAPAs along with revision, review and approval.

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Propharma Group – Senior Compliance Consultant May 2012 – March 2013

Hospira Pharmaceutical

Provided quality consulting which included investigations, assisted in root cause determination and the identification of the

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appropriate corrective and preventive actions to support manufacturing plant and corporate activities.

Coordinated, developed, tracked and managed investigations per standard operating procedures.

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Conducted and composed formal investigations for plant quality issues such as batch review deficiencies, OOS and non

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conformances for equipment, medical devices and drug products.

Assisted in training new employees and refining training programs and delivered facilitated training as needed.

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Maintained understanding of all applicable federal regulations FDA, DEA, EU, ISO and CFR.

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Reviewed and approved complaints, investigations and CAPA’s to assure the proper documentation, coordination and resolution

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are thoroughly addressed.

Maintenance of Customer complaints, recalls, CAPA’s and field alerts in Trackwise system.

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Assisted with audit readiness by ensuring all audit materials are up to date (e.g., FDA responses, 483 and warning letters).

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Participated in regulatory and third party inspections and also supported internal and external GMP related Audits.

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Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive

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manner.

Assisted with planned audits/assessments of systems, which may affect product quality to evaluate compliance and corporate

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policies.

Maintained working knowledge and understanding cGMP, GxP (liquid dosages), GLP and Corporate Compliance Programs.

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Grifols Plasma Resources – Quality Assurance Supervisor December 2009 – May 2012

Ensured the total operation of the center was in compliance with facility SOP’s, state and federal (FDA) rules and regulations as

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well as OSHA and CLIA requirements.

Identified quality system related deficiencies. Developed, reviewed and approved CAPA’s as well as verified any appropriate

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follow up and corrective actions to bring operations into compliance and maintain sustainability.

Oversee the execution, documentation and review of internal and external audits.

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Created, reviewed and approved Deviations utilizing Trackwise by applying rigorous problem solving and root cause analysis.

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Performed Look back functions for abnormal test results and communicated with agencies in regard to donor risk as well as

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ensure the donor samples were managed appropriately and discarded in the proper manner.

Assisted in process and equipment validations: IQs, OQs, PQs and MQs.

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Supervised the review of donor records, quality control procedures, supply inventory management, proficiency testing, and the

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calibration, validation and maintenance of equipment.

Provided support and assisted other members of the Center Management team in efforts to meets the center and company goals.

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Management of Quality staff, including direction, assignment of work, development and training and delegation of tasks.

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Analyzed tracking and trending data, determine appropriate actions to improve trending and prepared reports with in depth

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research and analysis to resolve systemic compliance issues.

Host’s internal and external audits while maintaining compliance and quality standards.

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Routine monitoring of all staff with emphasis on achieving a more in depth understanding of tasks performed and applications of

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cGMP by performing direct employee observations and providing the necessary feedback.

Continuously assessed, promoted and improved the effectiveness of the quality systems in the donor center through recognition of

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trends, investigation of failures in the execution of procedures.

Demonstrated the ability to maintain a high level of quality and compliance utilizing good judgment, analytical skills,

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communication, problem solving and the management to balance multiple priorities with strong time management skills.

American Red Cross National Testing Lab – Lead Lab Technologist Infectious Disease March 2006 – December 2009

Provided direct and constant supervision for task performed by a staff of 25 laboratory technologist, technicians and assistants.

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Ability to understand and perform complex procedures and techniques and work with complex instrumentation.

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Ensured federal and state regulations, AABB standards, ARCBS Directives and cGMP were maintained and identified areas of

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improvement under the Consent Decree standards.

Recognized and identified testing irregularities, OOS, equipment problems, non conformances and other potential problems that

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may adversely affect test performance and results.

Participated in FDA audits, problem solving meetings and determined root causes.

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Trained and coached new staff, delegation of work assignments, hiring and development to ensure established daily goals were

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achieved.

Supported in process and equipment validations: IQs, OQs, PQs and MQs. Maintained daily calibrations and quality control

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parameters.

Demonstrated problem solving, critical thinking, decision making, organizational and leadership skills to meet deadlines.

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American Red Cross National Testing Lab – Lab Technologist II Infectious Disease August 2003 – March 2006

Performed automated and manual test procedures on blood samples to assure safety, potency and purity of the blood supply.

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Performed, reviewed and approved quality controls on products, reagents and equipment.

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Executed the required maintenance on all testing equipment and prepared and performed validations.

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Correctly interpreted test results to identify discrepancies and deficiencies.

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Provided work guidance and training for new technicians.

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Understand and compiled with applicable federal, state and local regulations.

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American Red Cross National Testing Lab – Quality Control Specialist III April 2000 – August 2003

Performed in process and documentation review of all laboratories testing including reagent qualification, proficiency testing,

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non standardized and investigative testing and reagent evaluation studies. Evaluate validity of test results prior to transfer and

release of valid results to the customer.

Conducted investigations and deviations as required for OOS, testing discrepancies and non conformances.

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Identified and investigated testing problems and implemented corrective actions.

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Management and execution of day to day functions of the various laboratories.

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Maintained detailed knowledge of laboratory policies and procedures.

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Performed internal audits of batch records, maintenance and training records.

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Sustained the use of good sound judgment as well as the ability to prioritize, organize and handle a high volume of workload

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efficiency.

Participated in departmental meeting for review of quality issues and resolutions.

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Maintained and organized test requests/results, calibration record, temperature charts and instrument manuals/service reports.

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Monitored and evaluated established protocols/SOP’s and recommended changes as needed.

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EDUCATION

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Johnson C Smith University – BS in Biology, 1997

North Carolina A & T University – Occupational Safety and Health (In – Progress May 2015)

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