Lamar Cousin

Experience

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  United States Air Force

  Feb 1992 - Aug 1998

  Sr. Airman
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  Alpha Therapeutic Corp/Baxter Plasma

  Jan 1999 - Jan 2003

  Regional Training Specialist

  Performed pre/post on-site quality audits for compliance at over 1/3 of all donor centersSupported, mentored and developed materials related to training and compliance for 9 donor centers (over 200 employees) including Management and Training Coordinators.Wrote PowerPoint presentations for Training Coordinator Seminars, Management Seminars, and company-wide annual cGMP training.Conducted teleconferences with donor centers on updates or revisions in procedures.Performed Freezer Validations for all designated donor centers to include compiling data, formatting data, writing and submitting final report.50% Travel to all donor centers and seminars locations.Reviewed and redesigned standard operating procedures for improvements and/or revisions.Developed over 20 new training documents for all 42-donor centers.Created, implemented and maintained spreadsheets and training for governmental required safety training completely eliminating inspections citations Show less

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  Alpha Therapeutic Corp

  Jan 1999 - Dec 2003

  • Performed pre/post on-site quality audits for compliance at over 1/3 of all donor centers• Supported, mentored and developed materials related to training and compliance for 9 donor centers (over 200 employees) including Management and Training Coordinators.• Wrote PowerPoint presentations for Training Coordinator Seminars, Management Seminars, and company-wide annual cGMP training.• Conducted teleconferences with donor centers on updates or revisions in procedures.• Performed Freezer Validations for all designated donor centers to include compiling data, formatting data, writing and submitting final report.• 50% Travel to all donor centers and seminars locations.• Reviewed and redesigned standard operating procedures for improvements and/or revisions.• Developed over 20 new training documents for all 42-donor centers.• Created, implemented and maintained spreadsheets and training for governmental required safety training completely eliminating inspections citations Show less

  • Regional Training Specialist

    Mar 1999 - Dec 2003

  • Training Coordinator/Team Lead

    Jan 1999 - Jan 2002
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  Donor center

  Jan 2000 - Jan 2002

  Interim Assistant Manager

  Recruited prospective donors through community presentations and advertising.Performed daily and weekly statistics.Interviewed potential candidates and provided input for hiring.Conducted performance evaluations for department.Contact Administrator for annual open enrollment of medical and dental benefits.Scheduled representatives from PPO and HMO administrators to explain changes to policies.Submitted paperwork with changes and ensured plan coverage began as designated.Developed and contacted local vendors and established contracts Trained all staff, management, and quality assurance personnel on policies and procedures. Show less

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  American Red Cross

  May 2004 - Aug 2019

  Advocated quality achievement, performance improvement, and technical innovation. Liaised with vendors, customers, internal departments, and senior management to continuously improve processes targeting quality control. Led risk management and capability studies. Authored quality, design, and technical documents. Resolved issues discovered during internal, customer, and certifying body audits using CAPA procedures. • Improved submission rates to FDA by combining and harmonizing recording groups; achieved accuracy rate of 98% and on time rate of 99%; maintained on time rate by streamlining documentation process.• Consolidating functions and team activities across 36 regions at two sites; slashed cycle time lags by 75%. • Implemented process changes to transform FDA reporting process; created templates to streamline Blood Product Deviation Reports and attained company’s highest First Time Right (FTR) submission rate of 97% to FDA. • Increased productivity and accuracy 20% by creating unilateral partnership with all quality and operations units to increase submission on time rates and levels of quality performance across all departments. • Selected to spearhead operational improvements as Warehouse Manager; leveraged innate organizational and leadership skills over two weeks to manage 100K sq ft warehouse with no previous experience; guided 20-member team, synchronized schedules, and deployed resources using 12 trucks between Durham and Fayetteville, NC area during substantial road closures; designed tracking system to safeguard smooth navigation to ten shelters and triaging warehouse; employed six additional drivers to coordinate truck relocations.Additional experience as Manager with Red Cross and Regional Manager with QA Problem Management, Cleveland, OH. Show less Volunteer work with American Red Cross (Sep 2018 Hurricane Florence)• 1st deployment for hurricane relief assigned as warehouse manager• Assigned to identify and deploy resources to deliver 12 rental trucks from Durham to Fayetteville area during massive road closures• Designed tracking system to ensure location was identified for all 12 vehicles as they were dispersed to shelters and to triaging warehouse• Managed a 100,000 square foot warehouse for receipt of donated goods including designing work flow of goods in warehouse that both met national guidelines and incorporated efficiency for storing and distributing• Identified local organizations where distribution of goods could be best utilized then dispatched resources to maximize efficiency and provide support needed• Established inventory system to readily have available goods received and to rapidly respond to request• Trained subsequent lead on systems and process to ensure smooth transition of services after volunteer time was concluded Show less • Developed standardized format for Post Donations Information (PDI) problems for 35 regions• Managing 12 staff and support personnel for day to day functions• Oversee identification and management of 1100 tasks monthly • Developed initial process flows for Problem Management day to day hand offs as well as Gain Control/48 hr FDA notification process• Facility Administrator for SCAPA • Participated in the development of specialized queries to capture volume of PDI problems • Hired staff (permanent and temporary) for multiple departments• Trained new staff in Problem Management and in SCAPA functions• Developed standardized program for PDI management Show less QA Problem Management 2007 -2008Manage staff of 8 for all regional departments deviations from procedures for resolutionDevelop, mentor and manage staff in meeting facilitation, root cause analysis, deviation management investigations, off site observations and evaluations through the use of data analysis tools like Stat-a-Matrix 7 step methodology and Cost of Quality Indicator systemsWrite performance reports, local operating procedures, job aids, data analysis spreadsheets and staff/supervisor curriculums Develop, deliver and maintain monthly in-service presentationsProject Manager for Cost of Non-Conformance for NOR ($60,000 project)Project Manager for Software implementation Show less Process Improvement 2005 - 2007Manage staff of four for Collections Department for department's deviations from procedures for resolutionDevelop, mentor and manage staff in meeting facilitation, root cause analysis, deviation management investigations, off site observations and evaluations through the use of data analysis tools like Stat-a-Matrix 7 step methodology and Cost of Quality Indicator systemsWrite performance reports, local operating procedures, job aids, data analysis spreadsheets and staff/supervisor curriculums Develop, deliver and maintain monthly in-service presentations Show less 2005Review controlled documents for release from Quality DepartmentWrite/Revise Standard Operating Procedures as dictated by National HeadquartersPerform reviews and audits of all areas and components of Biomedical Services DivisionRepresent Quality Department in Process Improvement Meetings, Facilities Renovations, and Inspection AuditsReview deviation from procedures for determination of appropriate action based on severity and including appropriate identification of scope Show less

  • Director Of Quality Assurance

    May 2004 - Aug 2019

  • Warehouse Manager

    Sept 2018 - Sept 2018

  • Manager

    May 2007 - Jan 2017

  • Regional Manager

    May 2004 - Jun 2008

  • Operations Supervisor

    May 2004 - May 2006

  • Quality Assurance Associate

    May 2004 - May 2005
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  Carolina Complete Health Network, Inc.

  Aug 2019 - Feb 2020

  Manager, HEDIS Operations
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  McLeod Addictive Disease Center

  Oct 2020 - May 2022

  Director of Compliance and Quality Improvement

  Oversee compliance to procedures for 9 locations throughout NC. Lead and represent company for audits with Drug Enforcement Agency (DEA), Department of Health and Human Services (DHHS) and Commission on Accreditation of Rehabilitation Facilities (CARF) including preparation and submission of licensing and certifications for multiple state and federal agencies. • Created Change Management system and program to mitigate risk with new projects• Created Deviation Management System to track and trend errors and facilitate corrective action/preventive action activities• Develop and implement internal auditing tools• Lead on relocation of main headquarters to new facility (with local, state and federal agencies)• Write and amend procedures• Chair Quality Assurance committee and assign responsibilities to sub committees• Oversee Medical Records department• Review contracts from LME/MCO• Review/Audit invoices• Perform Client Needs Assessments/Evaluate and investigate Grievances Show less

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  Scout Clinical

  Jul 2022 - Apr 2024

  Director of Quality Assurance and Regulatory Affairs

  Oversee both Quality Assurance and Regulatory Affairs departments. Stay apprised of International regulatory requirements involving clinical trials for concierge services. The company’s first Quality Assurance and Regulatory Affairs Director, I created, installed and maintained several systems to include Change Management, Internal Audit process, External Audit processes, Vendor Management audits and introduced Cost of Quality principles through American Society of Quality.• Install and oversee internal and external auditso The inaugural internal audit identified the need for specific KPI and implementation of new system to gather data for trending purposes• Install and maintain Change Management Systemo Resulting in identifying 10 critical changes requiring multi departmental collaboration for successful implementation• Install and Chair Quality and Sr. Management oversight of quality and metrics• Lead inaugural Vendor Management audit process• Creation of an internal International Resource Library for global compliance• Create companywide Tabletop Exercises for Disaster Preparedness• Managed multiple off-site client audits and responses• Review Regulatory/IRB/EC requirements for services provided Show less