Experience

LifeLink Foundation

• United States
• Hospitals and Health Care
• 100 - 200 Employee

• Q.A. Tissue Coordinator

  • Jul 2012 - Present

  • Responsible of the tissue recovery chart review to be release • Perform Variance report • Responsible to trained tissue coordinators with revised and new SOP's • Reviewing clinical course of donor’s case • Follow up completion of reports corrections • Responsible of the building management system alarms • Verification and follow up trends and graphs • Responsible of tissue policies compliance • Attend internal and external audits by foundation and federal agencies • Attend and discuss FDA audits Show less



Autoridad de Carreteras y Transportación (ACT), DTOP

• United States
• Facilities Services
• 200 - 300 Employee

• Laboratory Technician

  • May 2008 - Jul 2012

  • Knowledge in Federal Regulations, ASTM and ASHTO procedures • Slump determination of hydraulic Cement Concrete. • Performed Permeability Test. • Concrete Validation Design. • Sampling of Freshly Mixed Concrete. • Testing Compressive Strength of Hardened Concrete Cylinders. • Sample Receiving. • Performing Laboratory Certification. • Knowledge in Federal Regulations, ASTM and ASHTO procedures • Slump determination of hydraulic Cement Concrete. • Performed Permeability Test. • Concrete Validation Design. • Sampling of Freshly Mixed Concrete. • Testing Compressive Strength of Hardened Concrete Cylinders. • Sample Receiving. • Performing Laboratory Certification.



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Q.A. System Owner

  • Jun 2006 - Dec 2007

  • Responsible for life cycle of assigned equipment: include purchasing, commissioning, validation, maintaining and decommission of Q.A.L. equipment. • Scheduling and Review of work order documentation. • Provide input to SOP’S. • Write Impact Assessment Investigation for Work Orders, BMS Alarms, and for Laboratories of the building • Investigations report discuss with Q.A. Compliance Specialist. • Generate Work Orders for PM, CM, GM in Maximo 5.2. • Review and sign of Protocols. • Coordinate Work Orders activities and documentation. • Change Controls follow up. • Participate in Q.A.L. Work Orders Governance meetings. Participate in audits, initiatives and projects that may be departmental or organizational in scope for respond to client issues. Show less



Waters Technologies Corporation

• United States

• Chemical Operations Specialist Sales Representative

  • Apr 2005 - Feb 2006

  Management of Puerto Rico territory Waters sells. • Sell range of HPLC columns products/services in chemical operations to existing clients. • Analyzed market demands. • Presentation of sells status in comparison with budget and forecast. • Building database of potential clients. • Promoting Waters products to new clients. • Coordinating visit and Training to pharmaceuticals chemist and scientist HPLC columns chemical functionality such as Life Sciences, Forensics, Environmental, Food and Beverages. • Feedback and developing customer understanding product • Performed market activities for products. • Training analyst, supervisor, scientist and managers in brand product. Show less



Altyma Resources Management -Regulatory Compliance Division

• Compliance Certification Consultants

  • Jun 2004 - Apr 2005

  • Evaluation and Certification to Final Reports, MIR’s, CAPA’s, from Q.A., Crimp & Pack, Coating and Final Release areas. • Review the complete batch production, testing and control records for each applicable batch of Stents beginning with the production stage of the batch (also known as Coating Process), packaging and post-sterilization stage, including final testing for subsequent release. • Prepare a written report and certification, if appropriate, on each batch. • Assure corrective and preventive actions (CAPA) referred in the investigations reports are properly documented, sound (language, commitment dates, etc.) and understandable format. • Evaluation of operational/productions and processes and recommend/ Implement ideas for its improvements. • Evaluation of test methods and SOP’s Show less



Wyeth Pharmaceuticals Company

• Q.A. Technology Transfer Senior Sientist

  • Feb 1993 - Apr 2004

  • Coordinating and Preparing Training for Ethical and Technology Transfer personnel. Validation and Qualifications of Methods and new Products. Evaluation of LIR’s, DIR’s, KLER’s, and all kinds of Laboratories Investigations. • Troubleshooting to laboratory equipment such as HPLC, Gas Chromatography, Head Space Chromatography, Atomic Absorption, UV Visible, FT-IR, Dissolution, Karl fisher, Automatic Titration, pH meter • Performed all kinds of Laboratories Testing, using equipments such as HPLC’s, Gas Chromatography, and Head Space Chromatography. • Verification of temperature chart recorders • Performed IQ, QQ, PQ of Laboratory Equipments. • Reviewing all Laboratory Data and PM Report. • Analyze and Release of Raw Materials, Final Product and Stability Product. • Evaluated and approved Manufacturing Investigation report (MIR) • Participation in the SAP validation implementation. • Assists in performing C of A’s, APER’s and NDA’s Stability Report. • Preparing and reviewing CAPA reports. • Lead laboratory audits. • Performed Compliance reports. • Record reviewer for manufacturing area. • Released of Laboratory final reports. • Training analyst in Safety Ergonomics. Show less