Jason Morrow

**** ***** ****** ***** ********, GA 30088 Phone: 678-***-**** Email: acwr9p@r.postjobfree.com

Document Control Specialist

Over 13 years combined experience in clinical trials, environmental, research, and medical laboratory settings. Experienced in FDA, EPA, EPD, OSHA and cGMP regulated environments.

Areas of Expertise

•Clinical Trials: Management of the set-up process including database design, documentation, corporate communications, management of timelines/deliverables, logistics, kit building and customer service

•PC experience: MS Project, Word, PowerPoint, Access, LIMS, LIMS2000, StarLIMS

•Medical Lab: CBC, PSA, A1C, UA, HIV, HCV, syphilis, and other blood borne pathogens.

•Medical Device: HIV and HCV medical devices and diabetes testing equipment.

•Excellent written and oral communication skills with expert computer skills.

•Audits and deviations in FDA, OSHA, EPD, EPA and cGMP regulated environments.

Career Accomplishments

•Management of Clinical Trials of pharmaceutical companies including Eli Lilly and Alcon.

•Selected to work on research study headed by Georgia Tech researchers in the study of drugs in wastewater for DeKalb County Watershed Management.

•Created SOPs used in the qualification testing of equipment used in medical device production in accordance with FDA and cGMP standards.

•Reviewed monthly report of tests performed and charges assessed for WQC Laboratory/DeKalb County.

Career History

Document Control Baxalta/Shire, Social Circle, GA 2015-2016

Issuing official corporate SOPs, forms etc. Usage of corporate software in document processing. Management of employee training via ISOtrain. Writing SOPs to define Baxalta documentation process. Coordination of workflow between departments for maximum efficiency.

Set-Up Manager Quintiles, Marietta, GA 2012-2014

Management of initial set-up for clinical trials. Duties include database design, documentation of study progress, kit orders, data imports, result transmission and specimen processing. Open communication with sponsor requests for changes to meet expectations. Following FDA, OSHA, and global standards to ensure safety of the study for participants. Creation of study documents in accordance with company, FDA, and OSHA regulations. Experienced in global projects. Communications and coordination of services in the U.S., Asia, and Europe.

Quality Control Technician Facet Industries, McDonough, GA 2011-2012

Quality inspections of medical devices in a manufacturing setting. Communication with manufacturing department concerning product quality. Accurate recording of data. Creation of files, both physical and electronic concerning product quality. Issuing labels and other controlled documents to the manufacturing department. Inspection of incoming materials. Release of medical devices for shipping. Demonstrated proper procedures in deviations during production to ensure patient/consumer safety and FDA, OSHA, and cGMP compliance.

Laboratory Technician DeKalb County Government, Decatur, GA 2007-2010

Wet chemistry techniques including extractions, titrations, column separation and dilutions. Aerobic and anaerobic bacterial colony plating/counts. Media preparation. Maintenance and troubleshooting of technical equipment. LIMS data entry. Review of monthly productivity reports. Usage of technical equipment including spectrophotometers, evaporators, GC, microscopes, and AQ2 analyzers. Proper handling, storage and disposal of hazardous material. Accurate recording of data. Routine lab cleaning. Highly efficient productivity.

Case Coordinator QTC Management Inc., Atlanta, GA 2006-2007

Processing veterans’ disability claims in a team-based environment. Creation of medical exam forms used by physicians to assess veterans’ disability. Obtaining core lab results and x-rays in regard to patient disability. Communication with doctors, hospitals, and other medical facilities. Creation of files, both physical and electronic. Data entry. Excellent medical terminology. Continually met productivity goals.

Records Researcher ChoicePoint Inc., Duluth, GA 2005-2006

Conducting criminal background checks per employer request. Interface with federal and state databases. Creation of files, both physical and electronic. Professional handling of confidential information. Continually met productivity goals.

Research Assistant Clark Atlanta University, Atlanta, GA 2003-2005

Cultivation of prostate cancer cell lines LnCap, DU145, and PC3. Media preparation. Cell counts. Western Blot, RT-PCR, HPLC, and cell imaging. Proper handling, storage, and disposal of hazardous material including radioactive waste. Accurate record-keeping. Excellent sterile technique.

Manufacturing Specialist Visible Genetics, Suwanee, GA 2001-2003

Manufacturing HIV and HCV tests. Creation of SOPs used in device manufacturing process. RT-PCR. Wet chemistry techniques using Taq polymerase, dNTPs, buffers and media preparation. Ordering supplies used in manufacturing/clean-room environment in accordance with monthly budget. Excellent vendor relationships. Programming Beckman automated robots used in manufacturing process. Usage of industrial scale ovens, washers, and freezers. Accurate record keeping and data entry. Continually met company productivity goals. Proper handling, storage and disposal of hazardous material. Lab/Manufacturing Department Safety Officer.

Education

Bachelor of Science in Biology 1996

Xavier University of Louisiana

Master of Science in Clinical Research 2013

Morehouse School of Medicine

Contact this candidate