Rickie L. Myles

Dayton, NJ *****

***- ***-****

adgpr3@r.postjobfree.com

Professional Summary:

Responsible Quality Manager adept at providing guidance, leadership, and support in the quality of product and operations. Ensure all activities conform to applicable state, federal and international regulations, as well as follow company standards operating procedures and requirements. Will all ensure adherence to goals, objective and mission of the company.

Core Competencies:

oExcellent management skills

oProject Management

oDocument Management

oDEA Power of Attorney / ARCOS Reporting

oQuality Control Analysis

oStrong, team building abilities

oAseptic Processing

oGovernment, Third Party, Clients, and Internal Audits

oKnowledge of cGMP – 21 CFR – 210, 211, 820 USP 797, 503B, ISO 13485 & 14971

oQuality management tools, concepts, and methodologies

oSterile Compounding Processes

o Environmental Monitoring

oValidations

Professional History:

June 2009 – Present

Quality Manager – PharMEDium Services

Key Accomplishments:

oDeveloped procedures and implemented visual inspection process, a regulatory requirement. Reduced number of defects by 75% through use of quality problem solving tools that resulted in 250K in savings for IV bag final container family.

oReduce batch record review and release processing time by eliminating inefficiencies in the flow of supporting batch documentation.

oDesigned and implemented DEA Controlled Substance program for the facility.

oDeveloped and implemented Personnel and Equipment Tag Out / Reinstatement process for Laboratory Analysts, Environmental Monitoring Technicians, and Pharmacy Technicians, and equipment. Project savings resulted in $604K annual personnel cost savings and $1.6M equipment cost savings due to downtime.

oLEAN/Six-Sigma Methodology – Lead role in developing, planning, and implementing sterile compounding continuous flow process. Savings: $703K overtime plus $188K regular hours for one facility. Process implement across four facilities.

oReduce number of leaking 10ml syringes during compounding through root cause analysis and corrective/preventive actions $192K annual savings.

oSix-sigma project: Reduce scrap due to tube sets and plunger aseptic breaches. DMAIC process resulted in annual savings of $163K.

oLead the Automated Compounding Device implementation project for ISO5 area.

oQuality Management – Drove external supplier improvements through application of six-sigma methodology, developed quality plans, performed GxP audits, and root cause/corrective actions resolutions.

oLEAN - Developed process flows for analytical lab sample testing. Lead to 20% increase in testing capability.

oReview quality control results, investigate OOS Sterility, Endotoxin, and ID/Potency

oCollaborate with project owners and department heads on improvements continuous improvement projects.

oCollaborate with Engineering, R&D and all relevant and personnel in the development of projects, ensuring all aspects of project meet quality standards.

oManage the performance of 4 Supervisors and 12 quality assurance personnel

oConduct training classes, educating employee on their impact in the quality assurance process.

April 2005 – January 2009

Quality Program – UPS Supply Chain Solutions, Memphis, TN

oDirected Quality Internal Audits

oDevelop Audit Improvement Plans and reduced number of findings.

oEffectively executed Nonconformance / CAPA Adherence Program: Root Cause Analysis, Corrective Action / Preventive Action, Tracking and Trending that resulted in reduced internal and external errors.

oAudit SOP and client work instructions for procedural compliance.

oSupervised calibration process and performed validations.

oEnsure compliance with all applicable regulatory bodies (i.e., FDA, DEA)

oDevelop and Maintained Controlled Documents (i.e., SOP’s, Work Instructions, Forms, Manuals, Training Records)

oEnsured environmental compliance using TRANE Tracer Summit Environmental Monitoring System, Dickson Chart Recorders, Honeywell

oParticipated in FDA Audits

oDeveloped database and comprehensive training schedule for facility.

oResponsible for overall Compliance of Multi Client Healthcare Facility servicing 16 clients and 400,000sqft

oDetermined baseline customer satisfaction and process improvement needs through customer surveys.

oProactively create process improvements per accounts internally and externally. Organized single point of contact for domestic and international customers: Improved on time delivery and timely resolution of issues.

oPerform root cause analysis and develop process improvement for service failures across multiple business units i.e. Transportation and customs brokerage.

oEstablished and maintain metrics for DRS /SCS Scorecard reporting

oIdentify new business opportunities:

oLogistic experience (Air, Trucking, Rail and Ocean)

Education

MBA Healthcare Administration Belhaven University

BS – Business Administration Belhaven University

Professional Development

LEAN

KATA

Six Sigma Black Belt

Statistical Process Control

Core Problem Solving

Value Stream Mapping

System Experience:

Microsoft: Word, Excel, Power Point, Outlook, ASCTrac, Mini Tab, Master Controls QMS,

LIMS, Excel Smart Sheet, AS400, MRP, WMS, PKMS, DRS (Crystal Reporting System), Client Relationship Management Tools, (i.e. BIA, Charts, Graphs) CATSWEB, ARCOS

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