Warehouse Associate Shipping Receiving
Resume:
José Tirado Villafañe
Cargill quality assurance specialist
Springdale, AR 72764
***************@***********.***
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