Objective:
Seeking a position with a company where I can utilize my professional experience and obtain a leadership role in a medical/device pharmaceutical manufacturing environment.
Professional Skills:
Producing quality products with supporting process improvement and new product introductions
Knowledge of regulatory and compliance requirements including GDPs, GMPs, OSHA, ISO 13485 and FDA QSR’s
Excellent understanding of various manufacturing processes, yields, and equipment associated with medical device manufacturing
Support and work with other departments independently or within a team to develop and implement actions to resolve technical problems relating to minimizing rejects, backorders and field complaints.
Proficient in Inventory Control software JD Edwards and Enterprise Resource Planning
Proficient in Microsoft Word and Excel and in using ZEBRA 140 Xi machine for printing labels
Trained in First aid and CPR
Professional Experience:
International Technidyne Corporation/Accriva Diagnostics, Edison, NJ
Manufacturing Team Leader, 2008-2016
Responsibilities:
In-depth knowledge of Production Packaging and Assembly department
Interact with production planner, warehouse and quality personnel to coordinate product flow to execute the weekly production and packaging plan
Lead and motivate staff, monitor performance and delegate responsibilities of assigned personnel including job rotation, employee development and training.
Prepare and review production and packaging documents and submit in a timely and accurate manner
Identify and pursue ideas that reduce rework, provide cost savings and improve process
Responsible for initiating disposition for non-conforming product
Organize and control inventory assigned to department and perform cycle counts
Involved in Product Quality and Quality Improvements and follow Company Policies and Procedures, and FDA Regulations
Manufacturing Operator I / Technical Operator I and II, 1995- 2004/2004-2008
Responsibilities:
Responsible for completing manufacturing batch records reviews including; verification, reconciliation, accuracy of calculations and ensuring completeness
Performed various other tasks including auto assembly equipment, in process QC, component placement, visual inspection of devices and packaging finished goods
Education:
B.S. in Microbiology, India 1993