José Tirado Villafañe

Cargill quality assurance specialist

Springdale, AR 72764

adwflv@r.postjobfree.com

+1-479-***-****

Audit, line clearance,review batch records, inspect any deviation,HACCP. EHS specialist. Willing to relocate: Anywhere

Authorized to work in the US for any employer

Work Experience

Production Supervisor

Gotrg - Bentonville, AR

February 2020 to Present

Aware of any discrepancy and issues in production process. Responsible for quality, quantity, and in charge of more than 45 employees, from leads, safety coordinator and production teammates. Health and Safety Supervisor

Cargill protein - Springdale, AR

January 2018 to February 2020

Experience in pharmaceutical industry, experience in Quality Assurance responsibilities knowledge of manufacturing

operations of parental products manufacturing. Strong knowledge of relevant GMP, FDA, EU regulations and the ability to interpret and apply them for intended use. Knowledge of computer systems (Microsoft Office, Track Wise and SAP) Analyze data and interpret sampling testing results. AQL Sampling, parental product and Q

QA Scientist, Technical Specialist, Disposition Specialist PFIZER PHARMACEUTICAL - Arecibo, PR

August 2002 to December 2014

Arecibo, PR QA Scientist, Technical Specialist, Disposition Specialist Review batch for completeness and accuracy of data. Assign disposition to all finished products, bulk and intermediates when all release requirements are completed. Request corrections if necessary

Assure the proper physically and computerized systems (MAPS, SAP, etc), status identification (HOLD, RJ, AP, etc.) of raw materials, packaging components, intermediates and finished product. Verify expiration dates assigned for packaging products, as established for each. Reviewing of expirations dates correctness for packaging process. Verify re-evaluation dates and/or expiration dates assigned to bulk products and intermediates, following established

procedures.

Review and approve returned good evaluation and batch records. Participate in the internal audit program QASA (Quality Assurance Self Appraisal) Perform Line Clearance verification

Alert management of compliance issues

Keep and communicate metrics

Review COA to assure that the test result reported met specifications and was approved by a licensed chemist.

Prepare and request any additional information needed for markets and/or clients such as Certificate of Manufacturing and GMP compliance and any other documentation. Provide data for the Annual Product Review reports. Evaluate QAR's (Quality Assurance Reports), Laboratory Investigation Reports (LIR's) and Event Reports

(ER) to determine Quality resolution, as needed

Evaluate and approve documentation related to calibration and PM as needed. Participate on special project like Product Transfer, RFT initiate and M1 within others. Perform special project assignment as required.

Q.A. Inspector

ST. JUDE MEDICAL - Arecibo, PR

January 2001 to December 2002

Inspection of defects, delamination and other aspects that affect quality of units. Review, audit records or documents and assign release to all finished medical devices. Education

BA

Biology Pontificia Universidad Cat lica - Arecibo, PR 2001

Skills

• Shipping

• Shipping Receiving

• Warehouse Associate

• Packing

• Materials Handling

• Calibration (6 years)

• FDA Regulations (10+ years)

• Quality Inspection

• CGMP (10+ years)

• Quality Assurance (10+ years)

• Business Analysis

• Manufacturing

• Internal Audits (9 years)

• Microbiology (3 years)

• Laboratory Experience

• SAP

• User Acceptance Testing

• Agile

• Computer Literacy

• Quality Management (2 years)

• Research & Development

• Quality Control (10+ years)

• SQL

• Microsoft SQL Server

• Test Automation

• Requirements Gathering

• User Interface (UI)

• Microsoft Excel (5 years)

• Microsoft Word

• Microsoft Office (5 years)

• Clinical laboratory experience

• Customer service

• Basic math

• Microsoft Powerpoint

• Order fulfillment

• Spanish

• Dietary department experience

• Documentation review

• HACCP (3 years)

• Test cases

• Production management (3 years)

Languages

• Spanish- English - Expert

Certifications and Licenses

driver's license

March 2019 to February 2027

Forklift Certification

Class D Security License

May 2019 to February 2027

Class D non commercial. 15 PASGR

Additional Information

Skills

FDA (3 years), EXCEL (Less than 1 year), MICROSOFT WORD (Less than 1 year), SELF MOTIVATED (Less than 1

year), WORD (Less than 1 year), QA, QTP, Quality Assurance SKILLS

Fully bilingual (Spanish/English)

communication skills, and verbal. self motivated, creative and teamwork oriented. Excellent interpersonal skills

Knowledge of quality and compliance systems

Knowledge of FDA and internal regulations

Computer literate

Experience within Pharmaceutical industry

Knowledge in programs like Microsoft Word and Excel

Contact this candidate