Manager Quality

Roman Kidon

** ******* **** 908-***-****

Clark, NJ 07066 **********@*****.***

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Summary

Production MANAGER with experience in FDA regulated pharmaceutical / dairy

industry encompassing aspects of manufacturing and packaging processes.

Areas of expertise include troubleshooting of high-speed filling and

packaging equipment, managing set-up of lines for multiple product lots and

maintaining records in accordance with all regulatory requirements.

Self-starter with proven ability to grasp company objectives, plan

strategically and initiate process improvements to consistently achieve

goals.

Experience

FARMLAND DAIRIES. Wallington, N.J.

2008-present

PRODUCTION MANAGER

Managing manufacturing operations of production departments on three

shifts. Maintaining proper staffing levels. Setting priorities for

production schedules based on new product introduction, equipment

efficiency, and materials supply. Oversee the work efforts of supervisors.

Making budget recommendations on capital expenditures and labor.

Production Supervisor

Directing the production team to meet customer needs and achieve standards

related to cost, line efficiencies, waste, safety and productivity at ESL

plant.

. Ensuring proper CIP and sterilization of pasteurizing and filling

equipment.

. Maintaining daily production, HACCP and SQF inspection forms

. Applying knowledge of processes, equipment and system capability to set

challenging individual and facility standards within a plant.

. Achieving performance standards with regards to safety, line utilization

and quality.

. Ensuring that cGMP and SOP procedures are followed.

Pfizer, Inc., Brooklyn, NY 2005-2007

Packaging Coordinator (2005-2007)

Audited post-production documentation to track all products distributed to

packaging lines, identifying discrepancies and initiating and resolving

investigations. Managed daily operations of production lines.

. Monitored floor activities, provided timely feedback, and initiated

corrective actions.

. Provided accurate and completed production orders and associated

documentation.

. Delegated work assignments to team members to meet production schedule.

. Ensured proper calibration and documentation of product scales,

temperature/humidity recorders and packaging equipment prior to

production runs.

. Observed Good Manufacturing Practices while working around all products,

but not limited to proper documentation, training and gowning.

. Arranged maintenance, sanitation services and other personnel to achieve

the desired level and quality of production, safety and warehouse

services.

Lead Technician - Stability (2001-2005)

Verified product type, lot numbers, counts and expiration dates against

production order specifications.

. Supported shift line teams in achieving daily production performance

objectives while following safe work practices and GMP's under FDA

regulations.

. Performed equipment validation and line changeovers to run different

products in accurate and timely manner.

. Optimized equipment performance by adhering to specifications and

following SOP's.

. Documented all activities associated with work orders and equipment

corrective maintenance.

. Interfaced with department and QA Management resolving product quality

issues.

. Processed rejection and disposition of labels and various products and

controlled substances in form of powder, liquid and tablets in compliance

with FDA regulations.

. Improved productivity by performing product job set-ups, product sampling

and inspections.

. Trained colleagues on procedures, change controls and policies relating

to documentation including cleaning reports, logbooks, material movement

forms, reject forms and production orders resulting in improved knowledge

and performance in adherence with Standard Operating Procedures (SOP's)

and cGMP's.

Roman Kidon Page 2

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Packaging technician (1999-2001)

Operated, maintained filling and packaging equipment. Cleared modules and

inspected packaged products for quality standards. Met or exceeded

production goals and product quality standards by staging packaging

components and operating computerized packaging equipment in accordance

with production order specifications.

. Mastered work processes and documentation requirements for solid dosage

packaging lines.

. Operated and troubleshot high speed, computerized equipment in solid

dosage unit of pharmaceutical manufacturing.

. Adhered to environmental, occupational, safety and health (OSHA)

requirements while meeting or exceeding production goals and quality

standards.

. Reduced equipment stops and break downs through improved diagnostics.

Johnson & Johnson Cordis System, Warren, NJ 1996-1998

Clean Room Technician

Assembled and inspected coronary medical devices (stent delivery systems)

in 10000-category clean room according to process specifications.

. Ensured quality of medical devices by leak detecting inspection.

. Maintained printed packaging component inventory with 100% accuracy.

. Completed training on devices history and records assuring adherence to

regulatory standards.

Education & Professional training

Degree, Electro-Mechanical Technical School, Poland

Boiler room blue seal licensed

Specialized Skills

ISO 14001 trained Six Sigma training

OSHA trained

Completed Microsoft Excel, Word and

PowerPoint training

References Available Upon Request

Contact this candidate