JR

OBJECTIVE

My Career objective are to contribute in a positive way to the success of all assignments. I have work as a Senior Quality Associate for Global Quality CSV (Computer System Validation). The compliance systems used were Clear Quest and Quality Center/Test Director. I also have some experience with the TrackWise system reviewing change control request for Janssen Supply Group. With this assignment I also reviewed Change Control protocols for changes made to the JNJDOCS.

SKILLS

IT Support for small computer systems. Tracking systems for Samples. Validation testing and documenting of computer systems in the Pharmaceutical Industry.

JAMES ROBERTS

IT PROFESSIONAL/CUSTOMER SERVICE

931 TARAMORE LN; LEXINGTON SC 29072

215-***-**** E-MAIL:ads06c@r.postjobfree.com

EXPERIENCE

Data Prep/Data Entry: Palmetto GBA BlueCross BlueShield via Kelly Services December 2021 – September 2022.

Provided data entry for Medicare Provider Applications. Medicare Provider Program is a government program with rules and special forms to fill. Plus, other reports as specified by management to track productivity.

Customer Service Representative/ Inventory Clerk: PLCB Stores November 2015 – September 2021

I sold wine and spirits to consumers and Licensees. I unload trucks and deliveries. I participate in wine tasting events of our chairman selection of wines. I also help customers select wines and spirits. I hope to attain a wine specialist status.

Supervisor QC Laboratory: McNeil Consumer Products/Johnson and Johnson Consumer Health July 2014-November 2015.

I supervised a group of 4-6 individuals to qualify analytical methods for raw materials to certify the laboratory which was under consent decree. This was one of the final steps toward certification for manufacturing. The plant received certification notice

Pharmaceutical Consultant ValSpec/Proconex/Software Galaxy Systems

Jul 2004-Dec 2007; Jul 2011-Dec 2013

FDA Compliance Validation of Computer System through documentation and testing.

Companies: GlaxoSmithKline; Jansen Research and Development.

Systems: LabWare, Empower, ChemStation, Validation testing review through CLEARQUEST and Quality Center.

Customer Service Representative 2008-2011

ICT Group/SYKES, Langhorne, PA

Customer Care Associate at Abbott Diabetes Care phone support, to take care of customer complaints about their glucose meters.

Programming meters, training, daily operations.

Senior Laboratory Computer Consultant (May 1978-Apr 2004) Janssen Pharmaceutical (Subsidiary of Johnson and Johnson)

1000 North Route 202, Raritan NJ 08869

Provide Computer Support for Laboratory staff. Provide Computer System Validation Documentation and Testing. First line system Software support for Laboratory systems. Conducted analysis for products and Raw Materials for Operations.

CALS Chromatography Systems; Chromplot Chromatography system; Lab Manager Sample Tracking.

EDUCATION

M.S. Computer Science, 1991, Villanova University;

Address: 800 Lancaster Ave, Villanova, PA 19085

Phone: 610-***-****

B.S. Chemistry, 1983, LaSalle University;

Address: 1900 W Olney Ave, Philadelphia, PA 19141

Phone: 215-***-****

PA Secondary Education Certificate Chemistry TCIP Program Delaware Valley University;Address: 700 E Butler Ave, Doylestown, PA 18901

Phone: 215-***-****

SPECIAL TRAINING:

oTeacher Certification PA Chemistry.

oMicrosoft Certified Professional MCP Windows 2000 Professional – April, 2001

oOracle Training for DBA certification-September 2001

oIntensive 5-day Training Program Covering FDA Requirements for CGMPs, Computer Validation & Electronic Records / Electronic Signatures (21 CFR Part 11), QA Edge, Inc. April 30,2004

oCleaning Validation Introduction – May 18, 2007

oIn-House training on technical writing and data review – May –1992

VOLUNTEER EXPERIENCE OR LEADERSHIP

Cub Scout Leader for Pack 68 Dublin, PA Buck County.

Served on the board of Quakertown Chapter of Compassionate Friends.

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