Manager Customer Service

WALTER F. MICHITSCH

** ***** ****** • New City, New York 10956 • 845-***-**** • l4p8t2@r.postjobfree.com

TECHNICAL SERVICES / PRODUCTION SUPERVISION / MANUFACTURING PROCESSES

Successful and progressive experience in all aspects of nuclear pharmacy services, pharmaceutical product production, coating, encapsulation, granulation, imprinting, pharmacy, and compression. A track record of significant accomplishments in fast-paced environments where superior time management, project coordination, staff motivation, and cost containment skills provide the basis for success. Full knowledge of various manufacturing procedures including GMP, SOP and cGMP. Able to establish a team-spirited environment through a positive and proactive leadership style. A highly motivated and dedicated individual with superior work ethics, integrity, and the ability to consistently achieve objectives.

CAREER HISTORY

LifeCell Corporation, Branchburg, NJ 2010-Present

Production Supervisor of Production Operations

• Responsible for all 2nd shift operations which include: production, inventory control, payroll, facilities, maintenance, process improvement, training, EHS compliance and GMP investigations.

Cardinal Health, Nuclear Pharmacy Services, E. Rutherford, NJ 2009-2010

Manager, Chemical & Pharmaceutical Operations

Responsible for all Operations aspects of Cardinal’s PET business including production, inventory control, supply chain, facilities, maintenance, engineering, process improvement, and formulations improvement.

P.F. Laboratories, Inc.Division of Purdue Pharma, L.P – Totowa, N.J. 2001-2009

Production Manager-Narcotic Manufacturing 2008-2009

• Responsible for managing and directing staff in production operations

• Scheduled and tracked production to comply with customer delivery requirements

• Revised all batch records and SOP’s to reverse a series of FDA 483’s and warning letters which led to 3 consecutive successful FDA inspections

• Totally revised all narcotic handling procedures and improved the plant’s DEA compliance record

Senior Manager – Packaging Department 2006-2008

• Coordinate with Planning Departments to schedule and complete production requirements, while monitoring equipment maintenance program and packaging equipment qualifications

• Responsible for ensuring all packaging operations and packaging materials management are in compliance with FDA, DEA, and cGMP’s regulations

• Established and developed training curriculum for packaging personnel in coordination with the Training Departments

• Responsible for writing, approving, and implementing all departmental SOP’s and departmental investigations

Production Manager – Contin Manufacturing 2005-2006

• Responsible for shift operations of Totowa plant site including dispensing and manufacturing

• Ensure production schedules meet customer deadlines and provide superior client service

• Manufacturing representative for Safety, member of Hazmat/Confined Space Rescue

Senior Production Supervisor – Manufacturing / Packaging 2001-2005

• Managed and motivated approximately 30 packaging personnel and 5 packaging mechanics on 4 packaging lines over two shifts in the day to day operations in order to produce a quality product while ensuring strict compliance with all SOP’s, cGMP’s, FDA, DEA and OSHA regulations

• Scheduled and coordinated the daily packaging operations based upon available labor in order to meet customer service requirements

• Developed and delivered training for Production Operations personnel which included the use of comprehensive technical training modules with individual development plans

• Managed the issuance and control of Class II narcotic from the in-process vault in manufacturing

Walter F. Michitsch – Page two_________________________________________

Wyeth-Ayerst Pharmaceuticals (American Home Products) – Pearl River, New York 2000 - 2001

Production Supervisor  Consumer Health Products

Oversee all first shift production for this division that employs 25 operators and product processing staff. Deliver safety and SOP training, production monitoring, and editing of Kronos payroll system. Write and revise SOP’s. Respond and resolve to quality assurance audit observations in manufacturing. Assist engineering in scheduling PMO’s and calibrations of manufacturing equipment.

 Serve as Zone Captain, responsible for performing weekly zone audits of equipment and buildings, report observations, and coordinate with engineering to conduct repairs and/or replacements.

 Averaged a 90% - 95% attainment of estimated monthly production for the first half of 2001.

Clairol (WWBC) / Bristol Myers Squibb – Stamford, Connecticut 1999 - 2000

Production Supervisor

Supervised the second shift weighing operation for this global corporation, which generates $18 billion in annual revenues. Provided comprehensive production planning and scheduling support for this 24 x 7 operation of Clairol’s Worldwide Beauty Care Division. Identified and resolved operating difficulties.

• Improved production and technical training; motivate by example and encourage a team approach.

• Continually trained and updated in Good Manufacturing Practices and Environment Health and Safety Standards; incorporated new information in Standard Operating Procedures.

Par Pharmaceutical / Pharmaceutical Resources - Spring Valley, New York 1992 - 1999

Production Supervisor

Oversaw operators and mechanics involved in all aspects of coating, granulation, imprinting, pharmacy, and compression departments for this $50 million per year producer of generic pharmaceutical products. Provided input in the coordination of new product launches and revisions to existing products.

• Achieved new production records through the implementation of improved production and technical training and introduction of a team approach.

Barr Laboratories, Inc. – Pomona, New York 1984 - 1992

Production Supervisor

Supervised the overall manufacturing and packaging processes of one of the company’s major product lines. Monitored flow of incoming and outgoing inventory of raw materials, equipment and supplies. Ordered product labeling and packaging components.Trained, scheduled and motivated staff; assessed operator and mechanic performance and resolved related problems.Wrote and implemented departmental SOPs. Generated and analyzed batch record reviews and investigations.

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EDUCATION

• Dominican College - Blauvelt, New York • Bachelor of Science in Business Administration

• Pace University - White Plains, New York • Business Courses

• Continuing Education - Completed intensive, company sponsored management and technical training; courses including Situational Self Leadership, Self-Directed Work Teams, Film Coating Technology, Statistical Process Control, Hazard Communications Program, Lock/Out-Tag/Out Programs and Control, and Care of Compression Tooling.

• Computer Skills - Computer literate in a PC compatible environment.

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