Quality Control Project Manager
Resume:
KARLA SHAVER
Clearwater, FL 33760
***********@*****.***
PROFESSIONAL SUMMARY: Results-driven manager with eleven years of project
management, quality control, budget development, auditing and process
improvement experience. Managed an award-winning Quality Control team,
contributing to a double-digit retention of customers. A leader in the
development and professional growth of associates through effective
training and mentoring strategies.
Key competencies include:
. Quality assurance, monitoring and auditing
. Create and execute process improvements
. Ensure project and procedure compliance
. Budget development and utilization
. Statistical and trend analysis
EDUCATION:
Master of Business Administration: Baker University, Overland Park, KS
Bachelor of Arts - Psychology: Ottawa University, Overland Park, KS
EXPERIENCE:
Dentsply TDS July 2010 - June
2012
Project Manager and Lead Internal Auditor
. Develop and implement streamlining, cost cutting and time saving
procedures.
. Create and implement standard operating procedures to achieve corporate
and regulatory compliance.
. Lead projects to improve CAPA and NCR processes, producing a $50,000
savings over previous year.
. Process improvements leading to a 41% decrease in rework.
. Project management including verifying compliance with FDA, EU, Health
Canada and ISO 9000 standards.
. Member of internal audit team for quality and regulatory requirement
verification.
. Assess and resolve problems while executing responsibilities of quality
function.
. Verify quality of all division products and marketing materials.
. Provide design leadership for new product development and assist in
creation of technical master files.
. Ensure all resource management processes operate effectively and
efficiently.
. Assist in new product 510K submission to the FDA.
Quintiles Transnational October 2008 -
June 2010
Senior Clinical Trials Specialist
. Apply statistical and trend analysis, process capability, reliability,
validity, qualitative assessment, survey results and benchmarking to
drive improved results.
. Evaluate quality system auditing process.
. Analyze study documentation, track invoices and purchase orders to ensure
compliance with budget guidelines.
. Manage case reports, queries, clinical data flow and resolve
discrepancies within separate team functions.
. Assist with marketing projections for clients and research sites.
. Submit protocol specific information and clinical documentation to the
Institutional Review Board.
. Review performance measurement data and implement appropriate action.
KARLA SHAVER
6550 150th Ave North Phone:
Clearwater, FL 33760
***********@*****.***
PRA International April 2005 -
October 2008
Data Quality and Staff Scheduling
May 2007 - October 2008
. Ensure scheduling, training and staffing within annual budget guidelines;
decreased excesses by 28%.
. Perform data audits to ensure project and procedural compliance.
. Facilitate and conduct training, coaching, counseling and employee
development.
. Conduct quality control audit checks for clinical procedures and case
reports.
. Quality review of source documents, case reports, research study
calendars, flow sheets, schedules, forecasting and weekly KPI reporting.
. Document and report all errors, omissions, deviations and violations as
part of the audit process.
. Prepare training material and case study instructions for clinical
employees.
. Schedule and conduct training for staff in areas of quality control and
report completion.
Quality Control Manager April
2005 - May 2007
. Streamline the Quality Control process by designing and implementing new
procedures and written guidance documents, securing a 22% increase in
customer retention over the previous fiscal year.
. Perform internal audits for corporate, Institutional Review Board, client
and regulatory compliance.
. Manage, train, mentor, supervise and provide feedback for staff;
including creation and implementation of performance improvement plans
and establish monthly team goals.
. Coordinate the collection of quality management data, ensure accuracy of
data collected and determine corrective action for defects found.
. Mediate with internal and external customers to achieve KPI specific
goals.
. Host for clients, regulatory authorities and the corporate Quality
Assurance department during audits.
. Evaluate, prepare and administer quartile review appraisals for assessing
merit increases.
. Review employment applications, interview new hire candidates and assist
in hiring process.
Olathe Medical Center April 2000 - April 2005
Lead Medical Records Analyst
. Process improvements and implementation decreased outstanding balances by
over two million dollars in twelve months.
. Maintain Joint Commission and CMS regulatory compliance.
. Develop and manage organizational procedures for notification of
delinquencies.
. Design and execute monthly quality report for physicians in the
organization.
. Coordinate receipt of accurate data for monthly reporting to the
Executive Committee and Risk Management.
. Research monthly delinquency figures, identify problem areas and contact
appropriate personnel to resolve situations.
. Analyze records for missing documentation to ensure complete and accurate
records.
. Maintain integrity of the master patient index by reviewing and
investigating discrepancies.
. Submit weekly correspondence summarizing delinquencies.
VOLUNTEER:
. Relay For Life: Team Captain
. YMCA Challenger Program with Special Needs Children
. Special Olympics Coach
Contact this candidate