Frank P rez

** ********** ***. ***** *** Wallington NJ 07012

787-***-**** acb3bz@r.postjobfree.com

Summary of Qualifications

Professional with strong and vast experience in Pharmaceutical, Medical

Devices, Consumer Goods and Educational field. Strong leadership and

management skills, supported by a solid background in the areas of

Operations, Manufacturing, Filling, Packaging, and Human Resources. Strong

knowledge and experience in Solid and Semi-Solid Dosages Manufacturing

Processes such as Pharmacy Dispensing, Granulation, Blending, Compression,

Seal, Sugar & Film Coating, Polishing, Printing and Packaging processes.

Ability to perform multiple tasks, projects, and manage daily activities

under-pressure environment. Passionate about improving process and people

behaviors. Experienced supervisor with ability to work in a self-managed

work team environment. Organized person, responsible, proactive and a team

player, always willing to provide support to peers at all levels. Bilingual

English and Spanish.

Experience with QSR, cGMP'S, SOP's, OSHA, EPA, FDA regulations, ISO, and

safety. Expertise an Investigation procedures including CAPA through SAP.

Expertise in Lean Manufacturing, directed Kaizen and 5S events, Value

Stream Map, 7Waste Reduction, Kanban, JIT, TPM, SMED, Poke Yoke, POUS, OEE,

Visual Management, and Color Code. Six Sigma, SPC, DMAIC, SIPOC, CTQ, FMEA

and Team Building. Computer literacy in Microsoft Office: (Word, Excel,

Power Point) Outlook, Group Wise, CATSWEB, SAP, Track Wise, CAPA, Kronos,

Plateau, Wind-chill, ISOTrain, GxPharma, MATT, MES, PRISM, Falcom,

Navigation, MP2 and Internet.

Professional Experience

GlaxoSmithKline, Clifton, New Jersey

First Line Manager 2010 -

Present

. Responsible for the management of all operations occurring on the

second shift, these operations include sanitization, filling,

packaging, quality control & assurance, warehouse and plant

engineering activities. Also for the management of mechanical staff

that support all aspects of filling and packaging operations.

. Coordinate site activities through the planning with department

managers to ensure that packaging and preventive maintenance

objectives are accomplished in timely and cost effective manner and

supported technology personnel during validations and calibration

activities.

. Management the Packaging of high quality products to support Global

Consumer Healthcare Business to achieve the business drivers of

safety, security, compliance, quality, cost reduction, cGMP,

production and customer services.

. Provide direction, development and leadership to Enhance Team Leaders

(ETL) & subordinates.

. Manage and coordinate various programs essentials to Manufacturing,

Packaging procedures (e.g. training, safety, continuous process

improvement, cost reduction and recycle programs).

. Responsible for implementing strategies to increase efficiency,

improve quality and machine availability and encourage an environment

of continuous improvement.

. In the absence of more senior management on site, represent the

organization to all outside contacts (e.g. Police, Fire and Regulatory

agencies).

Achievements

. Evaluated, analyzed the packaging process flow and designed and

implemented the packaging summary board to facilitate the

communication and the shifts interchange between the packaging

Supervisors, Mechanics, Technicians and Operators.

. During the SOP's reading as part of the job training identified

several typo errors, incorrect issues, SOP's with different formats,

submitted these changes to Quality Documentation Department for the

corresponding update actions.

. Implemented Safety & Quality Muster meeting at the beginning of the

shift. The first team achieved more than 550 days without accident.

Four consecutive months without document errors.

. Implemented Manufacturing Lots Kanban System, & daily Gemba Packaging

Meeting per shift.

. Saved New Product Launch (NPL) of 2.2MM on line 19, customer received

the product on time.

Frank P rez Page 2

Pfizer (Wyeth), Guayama, Puerto Rico

Manufacturing / Packaging Supervisor 2006 -

2009

. Pharmacy, Granulation, Blending, Compression, Seal, Sugar & Film

Coating, Polishing, Printing Manufacturing and Packaging Areas

Portfolio of Products (Advil Regular, Advil PM, Advil Cold & Sinus,

Advil Gel Caps, Allergy Sinus, Axid , Advil Liquid Gels and New

Products)

. Ability to work a flexible schedule to include weekends as needed to

resolve production issues.

. Directed and executed multi-disciplined assignments including the

allocation and utilization of department resources in packaging and

manufacturing areas as assigned.

. Analyzed production problems, and performed investigations, determined

the roots causes, and recommended and implemented actions to be taken

to improve the processes, productivity, safety, and budgetary

performance; Audited area for safety and Compliance on a daily basis.

. Analyzed and project capabilities/efficiencies and manpower

requirements and prepare the daily and weekly work schedules based on

the Monthly production plan

. Trained and certified personnel on SOP's for Manufacturing procedures,

documentation, and regulatory requirements including cGMP's to comply

with regulations and guidelines.

. Coordinated and supported technology and facilities personnel during

validations and calibration activities. Participate in the design and

development of new equipment, and processes.

. Developed and supervised 71, manufacturing, packaging and inspection

operators.

. Reports equipment malfunction and coordinate repair to ensure least

amount of downtime.

Achievements

. Led the new product launch of Advil Strength, 160 lots 2 months ahead

of the schedule.

. Developed and implemented line balance to maintain continuous flow in

manufacturing (Coating, Polishing and Printing area), Implemented lean

manufacturing and process excellence methods

. Developed and led the implementations of documentation plan.

Established plan to monitor documentation errors & evaluated, trained,

re-certified the operators in cGMP and the mfg area improved from 70%

to 97%.

. Analyzed and implemented a Generic batch number from Pharmacy to

Blending in order to create flexibility in Compression area, the

productivity in Mfg 1 was increased by 38%.

. Improved by 20% the efficiency of the 3rd shift operations by

retraining, coaching operators and implementing a new layout of the

production area thus saving approximately $150K per year.

Guidant, Dorado, Puerto Rico

Manufacturing Supervisor 2000 -

2006

Rola, DSP, Drugs and Tips Manufacturing Areas

. Reviews production orders or schedules to ascertain product data such

as types, quantities, and specifications of products and scheduled

delivery dates in order to plan department operations.

. Plans production operations with manufacturing operators, establishing

priorities and sequences for manufacturing products through the

molding and extrusion processes.

. Coordinates mfg activities to ensure production and quality of

products meets specifications and complies with the required schedule

for internal and external (Biotronix - Germany) customers.

. Responsible for the effective planning, organization, control and

supervision of the drug manufacturing process and the objective of

optimizes of the process, resources and productivity.

. Supervised 43 production operators ensuring compliance with

regulations and company policies.

. Performed corrections and investigations, Action Plan for correctives

actions and Preventive Actions (CAPA). Monitor productivity metrics on

daily basis.

. Responsible for capacity planning, employee performance management,

attendance program, training & development and assertive disciplinary

progressive plan. Coordinated drugs (DXA) shipments to Germany.

Achievements

. Completed the DXP drug production for the next 3 years 2 weeks ahead

of the schedule.

. Reduced operators DXA Certifications by 6 weeks, saving $3,000.00 per

each mfg operator.

Frank P rez Page 3

. Reduced the DXA drug thru put by 7 days.

. January 2005 FDA & June 2005 BSI Audits - Zero Observations.

. Kaizen Final Pack - reduce thru put 3 days to 1.8 days $200000.00.

. Quarterly Symbol Employee.

Brady Manufacturing Area

. Supervised 60 production operators, ensuring compliance with

regulations and company policies.

. Prepared, implemented and trained personnel on standard operating

procedures of product, components and process specifications complying

with regulations and guidelines.

. Developed the value stream map for Brady production line, analyzed and

implemented the improvements to increase the productivity, UPP and

eliminate the non-values activities.

. Standardized the workstations to facilitate the tasks and implement

the color code for cycle time.

. Supervised and coordinated shift operations. Managed Brady budget to

achieve financial goals.

. Performed investigations on CAN, NC, FDN, PTM and MI Yields.

Investigate and report all accident in a timely fashion.

Achievements

. Implemented Lean manufacturing tools such as 5s, Value Stream Map, 7

Waste Reduction, JIT, Kaizen, Kanban, Visual Management, and Color

Code.

. Created a rework process for 1624 units and saved $324,800.00

. Reduced the Overtime 10.00% to 0.36%, Monthly savings $5000.00

. Implemented the Heat Sealer machine for the sterile trays pack

product. Increased the output productivity by 40%. The manual tray

pack process was automated and the ergonomic issue was corrected.

. Reduced the Brady Thru put 2.8 to 1.8 days reduce 50 units in the

pipeline $10000.00

. Reduced the Humidity cure time 6 hrs to 2 hrs, Kanban size reduce 40

units $8000.00

. Reduced the absenteeism 6.0% to less than 1%

. Kaizen Gowning Area annual saving $300,000.00

. Implemented the Visual Bin Component Management system in Brady Mfg

Area which contributed to reduce saving $1.4M on inventory levels

annually across the whole plant.

. Kaizen Fineline Tray Pack saving $250,000.00

Millipore Co., Cidra, Puerto Rico

Process Engineer & Production Supervisor

Mixing & Polymerization Manufacturing Areas 1999 -

2000

. Responsible for installation, performance and maintenance of casting

production equipment.

. Provided preventive, corrective and predictive maintenance jobs to

production equipment.

. Responsible for mixing and polymerization manufacturing process and

mechanical engineering services in the manufacturing and packaging of

membrane sterile and non-sterile products.

. Provided direct technical support, evaluate & execute opportunities

for improve of current manufacturing process performance.

. Provide expertise and support the manufacturing in the day to day in

troubleshooting situations to keep the equipments running and reduce

the downtime.

. Provided support to Quality Department to maintain cGMP, and

production equipment in compliance with QSR, safety and sanitation

regulations and Millipore standards.

. Supervised five production operators and 3 mechanics engaged in the

manufacturing of membrane for filter products, ensuring compliance

with regulations and company policies.

. Provide technical training to Maintenance Mechanics in machine setups,

adjustments, and repairs needed to maintain machinery in optimum

conditions.

. Train the manufacturing operator on standard operating procedures.

Achievements

. Increased Yields by 20%.

. The J casting machine was automated PLC increase the productivity 25%.

. The mixing area was complete repaired 2 weeks ahead of the schedule.

Frank P rez Page 4

Colgate Palmolive, Juncos, Puerto Rico 1996 -

1999

Team Facilitator

Molding, Tufting, Seal & Packaging

. Facilitated the development and empowerment of the teamwork by

providing technical and social trainings. (Self-Managed Team Work

Philosophy).

. Improved the employee performance providing feedback and counseling.

Directed and coordinated all molding, manufacturing, inspection,

sealing and packaging activities related to the Consumer products

family.

. Developed and supervise 85 operators: Molding (6+1Mech.), Tufting

(30+5Mech.), Sealing (6+1Mech.), Bogo (5), IWKA (5), Intn'l (7) UBC

(4), Bulk (7), Quality Inspectors (3) and Material Handler (3) Group

Leader (2) operators.

. Performed adequate line balancing of manufacturing operations to

maximization the resources.

. Provided support to Quality Dept in process validation and experiment

manufacturing orders. Coordinated and supervised cycle count

inventory.

Achievements

. Reduced the cycle time Injection Molding by 28% (17 sec).

. Increased the output IWKA 800 to 1200 box increase the packaging

capacity 50%.

. Completed the Gripem's and Star Wars new product launch 1 month ahead

of schedule.

. Increased the Wave Production toothbrush from 8000 to 10000 units

(25%) $24000.00 per month.

Education

University of Turabo, Gurabo, Puerto Rico

Master Degree in Management and Material Control (In Progress)

University of Turabo, Gurabo, Puerto Rico

Master Degree in Human Resources

University of Puerto Rico, Mayag ez Campus

Bachelor of Science in Mechanical Engineering

Trainings and Certifications

. (CRM) Cardiac Rhythm Management Training (Brady arrhythmias,

Tachyarrhythmia's, Heart Failure)

. Time Management Training

. Ergonomic & Human Factor Training

. TQM, JIT, MRP, World Class

. Leadership Development

. Targeted Selection

. Injection Molding Training Engel's

. Train the Trainer

. Energy & Conservation Auditing Course

. Design, Evaluation & Interpersonal Relation Seminars

. Solid Dosages Training & Certification

. Project Management

. Lean Manufacturing (5s, Kaizen, Kanban, TPM, 7Waste, VSM, POUS, JIT,

SMED, Poke Yoke, Visual Mgmt)

. QSR, CGMP and ISO Regulations

. Six Sigma Introductory

. Statistical Process Control - SPC

. Water Purification System

. Self-Managed Team Work Philosophy

. Continuous Improvement Methodology

. CIAPR - E.I.T.

. Selection & Recruitment, Labor Legislation, Supervision & EHS

certification

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