*** Accomplished Management Leader:

Manufacturing Quality Control Quality Assurance ***

  Seasoned manufacturing leader with a work history of consistently exceeding performance objectives.

  Managed the manufacturing of healthcare products, including pharmaceuticals and medical devices.

  Experience using Lean Six Sigma methodologies to improve performance, including value stream mapping; DMAIC; 5S; 5why; Fishbone analysis; Kaizens; Process flow; and CAPA.

  Led operational parameters of equipment; batch record/processing dynamics; and integrated utilities to identify and resolve quality risk to commercial manufacturing.

  Hold both a Master of Project Management (MPM) and a Master of Business Administration (MBA).

  Experience adhering to current Good Manufacturing Practices (cGMP), ISO 13485 standards and U.S. Food and Drug Administration (FDA) regulations.

  Proficient with Microsoft Office, Project, Visio and Access; SAP; AS/400; Lotus Notes; Kronos; PRMS; and Trackwise software programs.

  Increased production output 40%, from 30,000 units to 50,000 units in one shift.

  Led an activity-based cost initiative that resulted in passing 100% of variances through the system.

  Lowered cost and enhanced quality after designing tools for operators to improve performance.

  Honored with a quarterly award for recording no errors on the production over 12 months.

  Spearheaded multiple changes to the production line that improve overall performance.

  Reduced NCI s by 50% within a 12-month timeframe.

Manufacturing Management Data Analysis Team Building

Production Management Investigations/Inspections Staff Training

Batch/System Records Continuous Improvement Auditing

Workflow Management Processes and Procedures Report Generation

Supervisor, Operations Management, Cardinal Healthcare Presource 2012-Present

  Lead, mentor and coach more than 100 production employees, including team leads.

  Establish priorities to improve workflow and evaluate the performance of individual team members.

  Collaborate with other supervisors and leaders of departments to achieve performance goals.

Supervisor, Manufacturing, Ciba Vision 2009-2012

  Managed more than 100 personnel dispersed across multiple manufacturing departments.

  Monitored performance on the production assembly line to achieve product release time deadline objectives, including auditing processes and scheduling staff.

  Trained personnel on policies and procedures regarding current Good Manufacturing Practices (cGMP).

Supervisor II, Manufacturing, Baxter Healthcare 2007-2009

  Supervised a team of manufacturing personnel to achieve product release time goals, including interviewing candidates and hiring and training personnel.

  Oversaw documentation for batch and system records.

  Communicated with officials with the U.S. Food and Drug Administration (FDA) regarding inspections.

Supervisor/Auditor/Corporate Trainer, Hospira, a Pfizer Co. (formerly, Abbott Laboratories) 1991-2007

  Promoted to positions of greater responsibility for consistently exceeding performance objectives.

  Honored with a quarterly award for overseeing recording no errors on the production over 12 months.

  Spearheaded multiple changes to the production line that improve overall performance.

Master of Project Management (MPM), Keller Graduate School of Management; 2011

Master of Business Administration (MBA), Healthcare Services, Keller Graduate School of Management; 2009

Bachelor of Science, Business Administration (BSBA), Health Services Management; DeVry University; 2008

  Completed Conflict Management Training.