Quality Control/Compliance/Assurance

Joseph Tran **** Florence Lane Bensalem, PA ***** Phone: 267-***-**** Email: aca6bd@r.postjobfree.com

EDUCATION Temple University

Bachelor of Science Degree in Biology

Graduation: December 2008 EXPERIENCE BPS c/o Morphotek Inc. Exton, PA

Microbiologist III

November 2012 – Present

Responsibilities:

• Initiate and perform lab assessments for Out of Trend (OOT) and Out of Specification (OOS) for experiment results

• Project Management: Project Lead for Validation of WINKQCL and Cleaning Validation program

• Perform internal audits of laboratories

• Supervise training and ensure deadlines are met for tasks

• Performance Qualification (PQ) of facility utilities ie. Nitrogen, Oxygen, and Compressed Air systems, as well as WFI and RODI systems

• Review of test results for in-process and routine testing

• Write and revise forms and SOP’s

• Implement Microbial trending procedure and microorganism library

• Perform routine Total Organic Carbon (TOC) analysis, Endotoxin, Nitrate, and Conductivity testing of Purified Water, WFI, and Clean Steam

• Manage in-process samples received from manufacturing personnel

• Performance Qualification (PQ) of Environmental Monitoring procedure

• Microbial identification with Vitek2 Compact

• Assist in implementation of LIMS

• Testing and analysis of Biological Indicators (BI); SteriAmp II and Attest

• Use of Kay Validator for Incubator and Refrigerator validation

• Mycoplasm testing with SYBR green from Applied Biosystems

• Perform mock preparation of IND and IMPD for regulatory submission

Fibrocell Science Exton, PA

Quality Assurance Associate

August 2012 – November 2012

Responsibilities:

• Review of Manufacturing Batch Records

• Quarantine and Final Disposition of Raw Materials

• Review of Quality Control testing data against established specifications

• Evaluate CAPA’s, and review and approve investigation and deviation reports

• Approval and disposition of all manufactured Drug Product (Bulk Drug Substance and Final Product)

• Manage manufactured drug product in controlled Liquid Nitrogen storage units

• Creation of Certificate of Analysis for released Drug-Product

• Review and Approval of Drug Product – Injection labels

• Prepare and review documents for FDA and regulatory audits

Lancaster Laboratories c/o GlaxoSmithKline King of Prussia, PA

Microbiologist II

May 2011 – August 2012

Responsibilities:

• Initiate and perform lab assessments for Out of Trend (OOT) and Out of Specification (OOS) for experiment results

• Write and revise specification edits for Raw Materials and QCC SOP’s, to conform to USP, EP and regulatory standards

• Conduct routine sampling of water (Purified Water and WFI) and Environmental Monitoring (EM)

• Gas testing of nitrogen, purified air, CO2 and oxygen.

• Perform testing on cleaning and in-process samples

• Perform routine Total Organic Carbon (TOC) analysis, Endotoxin, Nitrate, and Conductivity testing of Purified Water, WFI, and Clean Steam

• Testing of Raw materials

• Gown qualified for ISO 5, 7, and 8 areas

• Sterility testing of in-process materials

• Sterility and growth promotion for received QCC media

• Manage in-process samples received from manufacturing

• Validation and Preventative Maintenance of Milli-Q water systems

• Management of in-process retain samples stored at -70 C

• Testing of biological indicators (BI)

• Aseptic qualification training of new employees for use of Biological Safety Cabinets (BSC) and Laminar Flow Hoods (LFH)

Awards and Certificates

- Superlative Service Award – March 2012

Auxilium Pharmaceuticals Horsham, PA

QC Microbiology Analyst I

March 2010 – May2011

Responsibilities:

• Conduct routine sampling of Environmental Monitoring (EM) and water (Purified Water and WFI)

• Perform routine sampling and testing of Nitrogen and Compressed Air Systems

• Data input and verification of required specifications with use of MODA (Mobile Data Acquisition Platform)

• Enter and review data obtained for compliance to specifications and report abnormalities

• Perform routine Total Organic Carbon (TOC) analysis, endotoxin, bioburden, nitrate, heavy metal, conductivity and chlorine testing of Purified Water, WFI, and Clean Steam

• Perform System Suitability for Total Organic Carbon (TOC) analysis

• Maintain thorough understanding of GMP and GLP regulations and have applied this knowledge to ensure proper documentation to support testing procedures

• Maintain laboratory and lab equipment

• Perform trending of EM, water, and microorganism isolates

• Gown qualified for ISO 5,7, and 8 areas

• Viable Cell Count testing of product material to determine product potency

• Qualification of microbial media, microorganism and rinse solutions

• Perform identification of microorganisms with use of BBL Crystal and Vitek 2 System

• Coordinated with EU inspectors to ensure tests and methods meet EU requirements

• Initiate Investigation Reports (IR) including Out of Trend, Out of Specifications, Deviation Investigations (DI), and Corrective Action and Preventative Action (CAPA)

• Performance Qualification (PQ) of utilities (WFI, WDI, and Clean Steam) for manufacturing facility

• Aseptically qualified for Biological Safety Cabinets (BSC) for testing of sterile product and material

Aerotek c/o Medimmune Pharmaceuticals Philadelphia, PA Pharmaceutical Technician Specialist August 2009 - February 2010 Responsibilities:

• Quality automated system specialist in MODA (Mobile Data Acquisition Platform)

• Performed Environmental monitoring and managed samples within LIMS (Laboratory Information Management System)

• Batch record review to support regulatory submissions

• Real time review of batch record during production

• Quality control of sprayers during manufacturing to insure acceptable product

• Aseptically gown qualified for Class 100, 1,1000, and 100,000 production areas

• Comprehensive knowledge and understanding of GMP regulations

• Maintained aseptic environment in Class 10,000 and 100,000 areas

COMPUTER LITERACY Microsoft Word, Microsoft Excel, Microsoft Power Point, LIMS (ie. Labware, MODA), TrackWise

VOLUNTEER WORK

Greater Philadelphia Cares: November 2007 - Present

Philadelphia Marathon: November 2007 and 2008

Volunteer-A-Thon, Philadelphia Cares Day: October 18, 2008 LANGUAGES Fluency: English, Vietnamese REFERENCES Available upon requests

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