Quality Assurance Manufacturing
Resume:
NELSON VALLEJO MARTINEZ
Tel: 787-***-**** / Email: ********@*****.***
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: ********@*****.***
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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