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Quality Assurance Technician

Raleigh, North Carolina, United States
January 31, 2018

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Israel Allen

Raleigh, NC 919-***-****

Associate Scientist & IGIV-C Technician

Downstream Processing / Chromatography

Results-focused technical professional combining 11+ years of experience in validation, testing, and quality assurance roles in a pharmaceutical laboratory. Knowledgeable in GC, HPLC, UPLC, and TLC chromatographic instrumentation. Extensive background in collaborating on projects with cross-organizational and cross-cultural teams. Accomplished in maintaining knowledge of industry innovations, standards, and regulations. Credited with strong ability to identify trends, develop competitive strategies, and execute strategically planned projects.

cGMP & GLP Standards

Validation Methods

Performance Testing

QC Release

Lab Maintenance

Process Improvements

Technology Process Support

Stability Testing

Instrument Troubleshooting

Root-Cause Analysis

Safety Controls

LIR Investigations

Key Accomplishments

US Army Veteran that received an achievement award for a perfect score on PT testing.

Received a reward for identifying a wrongly labeled acid going into a product at Grifols.

Signed off on all equipment in less than six months, exceeding forecasts of one to two years at Grifols.

Professional Experience

Grifols, Clayton, NC

IGIV-C Technician, 2006 – Present

Leverage skills in chromatographic analysis (tailing factor, resolution, peak purity, purity angle/threshold, capacity factor, plate count) to isolate IgG protein. Scope requires processing of plasma intermediate material II + III paste through the dissolution and filtration stage, chromatography purification stage, and ultrafiltration/diafiltration stage in addition to Depth-Filtration to formulation and sterile bulking.

Increase accuracy in results by conducting tests using spectrophotometers, Biruret Assays, Conductivity, Turbidity, and pH while also validating techniques, aseptic, LAL, and microbial sampling of materials.

Uphold quality assurance by cleaning and sanitizing process areas, portable and miscellaneous equipment, and disposing of biohazard waste.

Champion efficiency with proactive measures in place to monitor deviations from targets and implement corrective and preventive actions that safeguard employees and products.

Improve statistical analysis by developing systems for tracking and trending of all data related to testing equipment/raw materials for processing, release, and the stability of the product.

Serve as a technical resource to laboratory teams, consulting on design control, process validation, process control, and risk management

Grifols, Clayton, NC

Sterile Filling Technician III / Backup Coordinator, 2006 – 2015

Navigated the complexities of serving in a multi-functional role by ensuring efficiency in performing activities as a technician, managing equipment and as a coordinator, assisting the team when needed. Role included oversight of fill/stoppering equipment, calibration, loading and unloading freeze-dryers, and operation of continuous air particulate monitoring system.

Minimized downtime in operations by ensuring functionality and setup of the highly automated aseptic filler and support for filling operations including glass bottle inspection, rinser/dehydrogenation tunnel, oversealer, and cage loader.

Acted as a resource, traiing new personnel and ensuring conformance to cGMP standards, requiring regular cleaning and sanitizing of aseptic filling areas and assembling/disassembling equipment on each fill station.

Highlighted results in reports of HPLC methods used for stability, performance and release testing of raw materials and final products in a cGMP environment

Delivered efficiency in testing by defining technical plans for achieving equipment readiness goals for test methods, characterization, and validation activities.

Education & Credentials

Bachelor's Degree in Psychology

Grendal University, Kings, NY

Master's Degree in Criminal Justice

Lorenz University, Montgomery County, MD

BioWorks Certificate, January 2012

Johnston Community College, Smithfield, NC

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