quality - Biotech Resume Search
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Desired Industry: Biotech SpiderID: 63123
Desired Job Location: Raleigh, North Carolina Date Posted: 8/15/2012
Type of Position: Full-Time Permanent Availability Date: aug 14 2012
Desired Wage:
U.S. Work Authorization: Yes
Job Level: Experienced with over 2 years experience Willing to Travel: Yes, Less Than 25%
Highest Degree Attained: MBA Willing to Relocate: Yes

obtain a challenging position within a competitive environment to develop my skills as a well rounded professional, as well as to utilize my education and experience to contribute to the success and well being of the company.

Apr 2012- Current Amgen
QA Specialist
Review Electronic Batch Records using Werum MES -PAS
Approve Batch Records.
Conduct Process Audit, related to the manufacturing process and cleaning validations (EUCR).
Conduct Facilities audit
Conduct Equipment Audits ( Verify standardization and calibration)
Provide Final Lot release verification and approval.
Audit Warehouse workflow and process checks.
Participate in WCT meetings
Approve documents.
Approve shop floor orders.
Approve Manufacturing orders.
Participate N.C. assessment meetings.

May 2008 Mar 2012 St. Jude Medical
QA/ Microbiologist
Perform supplier audits; classification of suppliers and monitor approve supplier list.
Perform document changes; implement new procedures and new process.
Audit area and divisional procedure and process.
Perform method transfer for several testing techniques (exa. Bioburden testing).
Manufacturing Controlled Rooms Quality auditor (gowning, documentation etc).
Peer Reviewer; Verify controlled documents data and verify validation protocols and reports.
Verify Product and Environmental Investigations. (exa. Non Conformance reports).
Perform CAPA investigations; implement corrective actions and tracking of effectiveness. Implement and develop CAPA s.
Sampling and analysis of environmental and water samples to determine presence of microorganisms.
Product Release via sterilization parameters evaluation. (Full knowledge of Gamma, E.T.O and steam sterilization.).
Laboratory equipment validations such as incubators, refrigerators, paperless chart recorders.
Conduct and prepare full environmental and product investigations. Evaluate product risk analysis using product FMEA standards.
Full knowledge of track wise, SAP, Mfg pro computer systems.
Participate in CAPA meetings, production daily meetings and Safety meetings.
Participated in the ISO 14001 Implementation team.
Conduct trend evaluation of environmental conditions and equipment behavior. (Via Pareto, P chart and different graph analysis).
Certify and give training to new personnel in gowning and clean room cleaning practices.
Validate and commission clean room requirements after shutdown activities.
Coordinate and evaluate clean room equipment movements. Identify possible product and process impact. Responsible for Clean room physical layout actualization and conservation.

April 2007- January 2008 Janssen Ortho LLC
QA/ QC Microbiology Analyst
Sampling and analysis of environment and water samples to determine presence of microorganisms.
Product testing to determine proper sterile conditions.
Gas monitoring (particulate viable or not viable).
Responsible for the implementation of numerous validations and qualification protocols.
Responsible for the documentation and results obtained on the tests conducted. Used the computer programs available to document and create the results.
Accountable for the continuous monitoring of the temperature and humidity conditions in the laboratory area. Had to maintain a level of both for the products being tested and solicited.

November 2006-April 2007 AMGEN P.R. INC
QAL Associate
Sampling and analysis of environment and water to determine existing microorganisms.
Identification of samples using various types of equipment protocols and transported by me to designated laboratory.
Gas monitoring (particulate viable or not viable) used proper equipment and prepared charts and graphics using the Microsoft programs and the lab programs established.
Sampling of TOC and Conductivity samples.
Responsible for establishing samples frequency and determining which conditions should they be sampled in.

September 2006-November 2006 CIQA Group
Validation Specialist in Janssen facilities
Accountable for the creation and evaluation of different protocols to test that the parameters observed are in compliance with the standards established on different standard procedures.
Responsible for the constant monitoring of different PLC and SCADA systems.
I was assigned to evaluate and redesign different protocols and procedures to be in compliance with different international regulations. These were brought up to date so that they could be used in the monitoring of the labs.

Bachelor Degree in Biology, majoring in Microbiology at the University of Puerto Rico in Humacao May 2006.
MBA Degree at Turabo University, concentration in Material Control & Management.
OSHA 30 hrs course certified in 511 Industry Standards.
Executrain certified in GLP (OOS investigations).
Practice versus procedure auditor, gowning and GMP trainer. Trained CQE (Quality Engineer)
Certified in sampling techniques described in ANSI/ASQ Z1.4 and Z1.9.

Fully Bilingual: Spanish/ English.
Dominion and Expertise of different sterilization techniques and practices (Ex. Gamma, Ethylene oxide and Steam sterilization).
Dominion of different techniques used in molecular sciences; such as: PCR, DNA sequencing and electrophoresis.
Expertise on the use of: GMP/GLP. ISO USP, EP, CAPA AND Non-conformance protocols.
Training on gas chromatography.
Training and development of numerous filtration techniques.
Training of Microscope, Analytical Balance, Autoclave, R2S and SAS air sampling. equipment. Certified on handling and disposing of Biohazard Waste and materials.
Comfortable working has a team and/ or with minimal supervision.
Complete dominion on different computer programs, for instance in: Microsoft Office XP, Excel, Word Perfect, Explorer, LIMS and E-lab.
Trained on how to document and illustrate the different information observed in the scientific laboratory tests.
Certified by Executrain for a 20 hrs seminar in GLP How to conduct an OOS investigation.
Certified by OSHA In standard 511 General Industries Requirements (30 hrs course)
Certified has a ground Coordinator for helicopter rescue.

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