Technician Manufacturing

Karen Rodgers Long

** ***** *********** **** ******, NC 27703

919-***-**** *********@*****.***

Manufactu ring Associate

QUALIFICATIONS SUMMARY

A self-motivated, multi-skilled technician with 13 years experience in ISO and GMP in the manufacturing industry, with the

ability to handle multiple tasks and adapt to constant changes and demands in a high-tech manufacturing environment.

Extensive accessioning experience using automated data systems to record and verify customer demographic data,

laboratory data and specimen data.

PROFESSIONAL EXPERIENCE

Pharmaceutical Process Technician Biomerieux (Volt) Treyburn, NC Oct 2011-May 2013

• LES Inspection-Post Oven Inspection of bottles.Bottle Assembly Operator, Filter Operator Trayloader Operator.

• Working with sensor bottles and filling blood culture media.

• Completing GMP documentation for all required activities.

• Performing proper cleaning of equipment and facilities.

• Communication of applicable shift information and scheduling of equipment to appropriate personnel.

Specimen Accessioning Technician Beckman Coulter Genomics (KSR) Morrisville, NC Nov 2010 – Sept 2011

• Receipt and proper accessioning of client samples into an automated data managing system (LIMS) according to

SOPs.

• Assess and document the integrity of samples as they are received and placing them in proper storage for

laboratory retrieval.

• Maintain proper documentation and/or chain of custody for manufacture and shipment of GLP, GMP, and GMP

regulated study samples.

• Collect and relay study related information to internal personnel and external customers.

• Serves as a liaison between lab operations and study management.

Pharmaceutical Packaging Technician United Therapeutics Corporation (LabSupport) RTP, NC Nov 2009 – April 2010

• Performed weekly cleaning of manufacturing suites using approved cleaning agent.

• Operated, set up, and monitored a variety of semi-automated and automated packaging equipment.

• Performed count checks, torque checks, and leak seal check of bottles filled

• Accurately completed all production packaging documentation throughout the fill process.

Manufacturing Technician I Catalent Pharma Solutions Raleigh, NC Oct 2006 - Jul 2008

• Properly setup and maintained the work area production equipment before and after each product operation run.

• Operated various production equipment: Hamo Steam sterilizers, Penntech vial parts washers, Sterline

Depyrogenation tunnel, Penntech tray loader, and filter test.

• Dispensed and weighed components used in production, experience in the operation of Orion pH meter, took

samples measured pH, Bioburden, Conductivity, mixed components and cleaned equipment.

K R LONG

• Verified and documented production batch records and logbooks manually and by computer to ensure equipment

and product specifications were met.

Manufacturing Operator I GlaxoSmithkline Pharmaceutical Zebulon, NC Dec 2005 - Oct 2006

• Provided daily manufacturing operations in the cGMP Solvent Granulation department.

• Recorded batch related information on batch material management systems in process software control systems.

• Performed disassembly, reassembly, and operation of critical pieces of manufacturing equipment.

• Equipment change-over to include minor repairs, mechanical and instrument set up.

• Performed in-process sampling inspection testing and disposition of product manufactured.

• Experience in the use of Aeromatic Fluid Bed Processor (Niro), Spray Wand, Metolift, Quadro Comil and Tote

Blender.

Manufacturing Associate II Biogen Idec Pharmaceutical RTP, NC May 2004 – Sept 2005

• Performed and executed daily manufacturing operations in the Dispensary group that included operation of

process equipment, execution of validation protocols, revised cGMP documents and other assignments as

directed.

• Accurate documentation of batch records, SLRS and equipment logbooks.

• Responsible for the cleaning, preparation, and sterilization of pharmaceutical equipment and delivery to various

manufacturing departments, adhering to GMPs.

• Maintained an up to date cGMP document training record using Isototrain.

• Certified on applicable SOPs pertaining to Equipment Preparation, Weigh and Dispense, Media and Buffer

Preparations.

Technical Team Member Becton Dickinson Treyburn, NC June 2003 – May 2004

• Assisted in setup and maintenance of equipment according to the company’s procedures.

• Packed and shipped finished good to inventory.

• Utilized complex techniques in cutting, stretching, and welding parts to produce pipettes.

• Counted pipettes using a handpack and blisterpack for packaging.

Multi-Skilled Technician Sumitomo Electric Fiber Optic RTP, NC May 1990 – Mar 2003

• Aligned various core and jacket preforms for the glass making machines.

• Attached dummy glass to cores and jacket preforms on vertical lathes to be used in the glass making machines.

• Recorded daily productivity output using company’s computer database.

• Studied and monitored calibrations of instruments and machinery to ensure process continuation.

• Recorded optical fiber using a telemeter.

• Performed all operational duties in the glass making and processing phase.

• Operated and monitored all equipment and products for quality and ensured attainment of production goals.

• Trained new staff in safety practices and organizational communication.

EDUCATION

Durham Technical Community College Durham NC Basic Laboratory Skills 2009

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Piedmont Community College Roxboro NC BioWork Certification

2002

Intra Med Institute Raleigh NC EKG Certification 1997

Danville Community College Danville VA Police Science 1984

COMPUTER SKILLS

Microsoft Excel, Word and PowerPoint; LIMS

REFERENCES

• Available upon request

K R LONG

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