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MAYA  SYDNOR 

309 Linslade Way                                                                                                                   (252) 822-9876

Wake Forest, NC  27001                                                                                         maya@msn.com

SUMMARY OF QUALIFICATIONS

Pharmaceutical compliance expert in parental and active pharmaceutical ingredient manufacturing as a pharmaceutical quality and operations manager.  Strong passion for team development and leadership as well as progressive creativity in implementing and sustaining programs leading to over $14 million in career cost savings.  Six Sigma and Lean expert with proven success implementing programs that optimize quality and manufacturing operations.  Experience managing 140 employees, with site quality oversight of 2700 employees in three plants and two countries. 

EXPERIENCE AND ACHIEVEMENTS

Hospira, Rocky Mount, NC                                                                               July, 2010 - Present                                     

·Held positions of Head of Operational Quality and Manufacturing Quality Manager.  Managed quality oversight for production operations in two US and one international plants consisting of 2700 employees through 6 quality managers and 110 Engineers and Technicians.

Head of Operational Quality

·         Developed organizational structure and process for real time quality oversight

·         Managed warning letter remediation for floor operations utilizing voluntary third party oversight

Manufacturing Quality Manager

·Lowered exception turn rate by 48% and increased ERs closed on time by 65% through streamlined investigation information transfer, creation of the Exception Coordinator function and the Quality Investigations Project Management system

·Implemented Quality on the Floor In Process Coordinators utilizing current approved staffing, reducing batch record corrections by 47%

·Implemented Quality on the Floor in packaging operations and increased presence in solutions and filling operations through Quality Technician restructure

·Restructured Quality Technician team to eliminate overtime

·Lead quality and operations start-up for Dominican Republic operations

·Developed cost of quality model for investigation cost impact to operations

                                                                                                                                                                                                           

Covidien, Raleigh, NC                                                                                      October, 2005 – July, 2010                                        

·   Held positions of increasing responsibility, including Quality Assurance Manager, Bottle Core Imaging   Superintendent, Syringe Core Imaging Superintendent and Pharmaceutical Production Supervisor

·   Black Belt Six Sigma Trained, Green Belt Certified

Quality Assurance Manager

·   Decreased past release inventory by 87% and exception turn around time by 79%

·   Lowered past-due release cycle time by 86% from 21 days to 3 days

·   Instituted development pathways for Quality Assurance and Production personnel as well as 360 monthly review

·   Lead site Batch Record Simplification, International Batch Release, Component Scheduling, Strategic Batch Release, Volume Reduction and Changeover Reduction teams

·   Developed cost of quality model for risk based analysis of customer quality concerns

·   Performed site audits of manufacturing facilities for compliance and Quality Improvement Program initiative

·   Worked with production and quality teams during FDA, IMB, ANVISA and customer compliance audits

·   Developed and launched In Process Coordinator roles for real time compliance monitoring and deviation review

Mark Sydnor                                                                                                                                         Page 2

Production Superintendent

·   Developed real-time OEE tracking and Pareto analysis for statistical evaluation of process performance for Production and Quality functions

·   Lowered changeover downtime by 33%

·   Utilized Black Scholes Option Pricing model for site project management and decision making

·   Restructured packaging department, increasing labor efficiency by $250,000/yr

·   Applied new USP guidelines for fill volumes to realize savings of $100,000/yr

·   Created and developed production engineering technician positions to improve cost savings and optimize quality and efficiency focus as well as to create a pathway for organic growth with the department

·   Managed up to 140 employees through 7 Supervisors, 2 Process Engineering Technicians and 7 Team Leaders

Production Supervisor

·   Developed statistical evaluation to recognize top performance and initiate development coaching

·   Developed operator pay for performance plan for APAP production department

·   Moved C-Shift production team from the fourth to first producing shift

·   Utilized Kaizen and lean development to lower changeover and batch cycle time

Johnson Matthey, Wayne, PA                                                                          May, 2002 – October 2005                      

·   Held positions of increasing responsibility, including Batch Process Engineering Supervisor, Process Control Engineer and Process Control Technical Supervisor

Batch Process Engineering Supervisor

·   Implemented batch improvements to increase batch quality from 60% to 81%

·   Lowered average process downtime from 2.5% to 0.77%   ($1,500,000/yr)

·   Lowered weekend overtime costs by 25%   ($200,000/yr)

·   Increased batch run-time capacity by 40%

·   Lowered Platinum, Rhodium and Palladium reclaim inventories by 38%

·   Managed a team of 8 Process Engineers and 40 Operators in 2 plants

Process Control Technical Supervisor

·   Lowered Loss to Yield from 1.3% to 0.69% ($3,000,000/yr)

·   Managed operations for catalyst manufacturing, including Union Management and ISO14000 implementation

·   Reduced changeover downtime by 40%, ($9,000,000/yr) as team lead using Kaizen management strategies

Food and Drug Administration, Washington DC                                 August, 1999 - February, 2000 

Chemical Technician

·   Developed process to determine the concentration of intermediates and color for D&C and FD&C dyes

·   Performed HPLC, filtration, total color analysis and chromatography to determine dye composition

·   Automated Column Chromatography sampling process

EDUCATION

 

North Carolina State University, Raleigh, NC                                                                    

Masters, Business Administration

Concentrations, Biotechnology Management and Finance

Virginia Polytechnic Institute and State University, Blacksburg, VA                               

Bachelors of Science, Chemical Engineering

Minors, Chemistry, Mathematics

Concentration, Business Management

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