NELSON VALLEJO MARTINEZ

PO Box ***, Cayey PR, ***37

Tel: 787-***-**** / Email: acwcb4@r.postjobfree.com

* ** *

EDUCATION

Associate degree

Quality Control Engineer Technology

Turabo University - Gurabo, PR

PROFESSIONAL EXPERIENCE

18+ Years

OVERVIEW

Experience in the pharmaceutical and

medical device industry with knowledge

in the areas of validation, manufacturing

processes and participation in

manufacturing investigations for solid

dosage, semi solid and medical devices.

Outstanding capacity to lead cross

functional teams to accomplish objectives

and to meet critical deadlines in fast

paced, high growth and dynamic

environments, within established budget,

corporative goals and in compliance with

regulations.

TRAINING / SEMINARS

ASQ – Certify Quality Technician

ASQ – Certify Quality Auditor

Lead Auditor - Certification

Green Belt - Certification

Yellow Belt - Certification

LIMS

Minitab

JD Edwards

Change Control (ADAPTIV)

NCR

Compliance Wire

QSR’s

cGMP’s

OSHA

ESH

21 CFR Part 820

21 CFR Part 210 & 211

SOP’s

ISO 13485

Cleaning Validation

Prevention of Human Errors

PROFESSIONAL EXPERIENCE

ETHICON Johnson & johnson., San Lorenzo, PR 2004 – Present Business Area: Medical Devices

Quality Assurance Technician

Evaluate and approve product control disposition according to the requirement and Quality System Regulations.

Submit changes and support implementation of change in the documentation system.

Maintain continuous alignment of project scope with business objectives and make modifications to enhance effectiveness toward the intended results.

Ensured compliance with company policies and procedure; led staff training initiatives to maximize productivity.

Review business statistics and determine areas requiring enhancement, which includes inspecting samples and formulating improvement policies to meet quality standards.

Performs data analysis and recommends disposition of material.

Use of Statistical Process Control Knowledge to make decision on the acceptances/rejection of the process/product.

Perform in process inspection with the application of several calibrated instruments like radius gage, optical comparators, pull tester, etc.

Perform the batch records review for product release.

Support the Engineering and QA Departments in validation activities and participate in nonconformities investigations, root cause analysis, NCR’s, and CAPA.

Support associates on defect awareness and specification requirements.

Evaluate and make decisions on day-to-day manufacturing QA related issues.

Conduct Process and Product Audits.

Train the new Quality Assurance Technician.

Update and maintain the training material for inspection and disposition of products. Addecco., Cayey, PR 2003 – 2004

Client: CIBA VISION., Cidra, PR

Business Area: Medical Device

QA Auditor

Inspect raw material, in process and finished product or audit its corresponding documentation to assure compliance against Acceptance Specifications and SOP’s. Apply knowledge of Good Manufacturing Practices on a daily basis.

Responsible for the inspection/audit of the raw materials, in-process and or finished product and its corresponding documentation for its final disposition. Perform a wide variety of inspections, checks, test, and sampling procedures and accurately document results. Comply with regulatory requirements (OSHA, FDA, etc.)

Recognized possible problem situations, which may cause deviations from anticipated results and alert Supervisor of such matter.

Control of raw material or products on Quarantine and their documents up to final disposition. NELSON VALLEJO MARTINEZ

PO Box 568, Cayey PR, 00737

Tel: 787-***-**** / Email: acwcb4@r.postjobfree.com

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AREAS OF EXPERTISE

Trend Analysis

SPC

Manufacturing Investigations

Change Control

Trainer

Automation Equipments

New technologies

Regulatory/safety compliance

Process improvements

Auditing and analysis

Training and development

Quality Assurance

Strategic planning

PROFESSIONAL EXPERIENCE; Continue

Shering Plough., Las Piedras, PR 2000 – 2003

Business Area: Prescription Oral Solid Dosage Drugs Senior Pharmaceutical Manufacturing Operator

Perform moderate to large complexity processes according to standard operating procedures in the manufacturing area (solids dosage).

Perform routine maintenance and cleaning of equipment as per respective SOP’s, setting up and perform complex operations of equipment, plus participate in manufacturing operations as well as blending, coating, compression, dispensing, granulations, lubrications and Packaging for use commercial or validation studies.

Recognize and report malfunctions and make necessary adjustments to equipment.

Assemble, disassemble, operate and understand equipment per procedures.

Perform equipment calibration checks, simple preventive maintenance tasks and equipment troubleshooting.

Disposition of raw material, chemical components from weighing area for process executions.

Distribution tasks to the associates according the manufacturing area, objective and company goals.

Coordinated with warehouse, raw materials, mechanic, laboratory and quality assurance associates of daily schedules in order to meet the manufacturing standard requirement on time.

Lead MFG associates and providing them working instructions. Shering Plough., Las Piedras, PR 1995 – 2000

Business Area: Prescription Oral Solid Dosage Drugs Pharmaceutical Manufacturing Operator

Perform moderate to large complexity processes according to Standard Operating Procedures in the Manufacturing Area (solids dosage).

Perform routine maintenance and cleaning of equipment as per respective SOP(s), setting up and perform complex operations of equipment, plus participate in manufacturing operations as well as Blending, Coating, Compression, Dispensing, Granulations, Lubrications for use commercial or validation studies.

Recognize and report malfunctions and make necessary adjustments to equipment.

Assemble, disassemble, operate and understand equipment per procedures.

Perform equipment calibration checks, simple preventive maintenance tasks and equipment troubleshooting.

Kelly Services., Humacao, PR 1994 – 1995

Client: Johnson & Johnson Baby Products., Las Piedras, PR Business Area: Cosmetic Products

Packaging Operator

Perform necessary machine adjustments to run the appropriate box configuration as needed to properly operate the machine accordance to specification.

Checks batch integrity and prevent mixed batches.

Remove each dispenser boxes from the offload conveyor and place it into the shipper box. During this process inspect the quality and condition of the dispensers box, noting the seals, and neatness of the box.

Ensure safe working conditions and practices in the department. SKILLS

Computer literate: MS-Word, Word

Perfect, Excel, Minitab, MS-Mail, Project,

and PowerPoint.

Excellent presentation and

communication skills (oral, writing,

reading) in English and Spanish,

Able to:

work under pressure and with

minimal supervision

independently understand, follow,

and implement instructions

lead projects demanding a high

degree of responsibility and

initiative

manage multiple priorities and

meet deadlines

Self-starter, responsible, highly organized,

excellent interpersonal relations, team

player, proficient in technical writing,

critical and analytical thinking, and

problem solving skills.

Contact this candidate