Deborah Johnson-Resume 02-01-2016
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Deborah A. Johnson Phone: (314) 435-0248 // E-mail: [email protected] Summary: Quality-driven and motivated individual with years of experience working for a Contract Research Organization (CRO), conducting Phase I Clinical Trials in support of pharmaceutical drug development. Experienced in quality assurance auditing and quality control. Solid understanding of applicable FDA, ICH, GCP and OSHA regulations and guidelines. Meticulous with well- developed problem solving skills. Able to work and communicate effectively with all levels of the organization to accomplish project goals. Able to compose and produce written reports effectively and efficiently. Successful in implementing changes and new company policies. Capable of making consistent, sound decisions as well as knowing when to involve senior staff members. Proficient with computers and Windows-based software programs such as Word, Excel, PowerPoint and Outlook. Professional Experience Express Professionals – Epsilon 01/2015 to 03/2015 Produced, sorted and packaged promotional marketing materials for mailing. Gateway Medical Research/PRACS, (CRO) St. Louis, MO 2002 - 2013 Compliance Coordinator 09/2007 to 03/2013 Ensured compliance with applicable regulatory guidelines and in accordance with established procedures and standards of the Quality System. Conducted audits of the clinical activities, CRFs and source documents for compliance with Good Clinical Practice (GCP), protocols, SOPs and other regulations/guidelines. Reported findings to applicable department Management; followed-up to ensure adequate completion of corrective actions. Contributed to the development, revision and implementation of Standard Operating Procedures (SOP) and Work Instructions (WI). 1
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Transcript of Deborah Johnson-Resume 02-01-2016
Deborah A. JohnsonPhone: (314) 435-0248 // E-mail: [email protected]
Summary: Quality-driven and motivated individual with years of experience working for a Contract Research Organization (CRO), conducting Phase I Clinical Trials in support of pharmaceutical drug development. Experienced in quality assurance auditing and quality control. Solid understanding of applicable FDA, ICH, GCP and OSHA regulations and guidelines. Meticulous with well-developed problem solving skills. Able to work and communicate effectively with all levels of the organization to accomplish project goals. Able to compose and produce written reports effectively and efficiently. Successful in implementing changes and new company policies. Capable of making consistent, sound decisions as well as knowing when to involve senior staff members. Proficient with computers and Windows-based software programs such as Word, Excel, PowerPoint and Outlook.
Professional ExperienceExpress Professionals – Epsilon 01/2015 to 03/2015
Produced, sorted and packaged promotional marketing materials for mailing.
Gateway Medical Research/PRACS, (CRO) St. Louis, MO 2002 - 2013 Compliance Coordinator 09/2007 to 03/2013
Ensured compliance with applicable regulatory guidelines and in accordance with established procedures and standards of the Quality System.
Conducted audits of the clinical activities, CRFs and source documents for compliance with Good Clinical Practice (GCP), protocols, SOPs and other regulations/guidelines. Reported findings to applicable department Management; followed-up to ensure adequate completion of corrective actions. Contributed to the development, revision and implementation of Standard Operating Procedures (SOP) and Work Instructions (WI). Supervised the Clinical Equipment department day-to-day activities.
Ensured that the Clinical equipment was calibrated, serviced, underwent periodic performance verification, and adjusted as necessary, to maintain the equipment accuracy, performance and reliability.
Verified that all documentation/operations were in compliance with company policies and regulatory requirements.
Established an appropriate maintenance, verification and calibration schedule. Worked directly with all appropriate staff to ensure proper calibration, operation,
maintenance and repair of clinical equipment. Established safety training requirements, developed training material and conducted
safety training for new and existing employees. Performed internal audits of facilities, processes and work practices for Safety
Program compliance.
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Deborah A. JohnsonPhone: (314) 435-0248 // E-mail: [email protected]
Developed an Emergency Action Plan (EAP). Planned and implemented emergency response drills. Reviewed results to assess their effectiveness.
Active member of the Safety Council and Safety Committee. Team leader for the Emergency Response Team (ERT).
Participated in professional associations and attended training events related to employee safety.
Quality Assurance/Quality Control (QA/QC) Specialist 07/2002 to 09/2007Ensured that all prepared clinical trials phase I study source documentation were complete and in accordance to protocols, SOPs and regulations.
Reviewed study files upon data entry at check-in, on study and post-study procedures. Observed the clinical procedures during the conduct of studies and made sure that they were performed in accordance to protocols, SOPs, GCP and regulations. Ensured that the study files after study completion were accurate and legible according to protocols, company SOPs, GCP and regulations.
Creations & Occasions by DEB, St. Louis, MO 2000-2002 Event Planner & Designer (Parties & Creations for all Occasions)
Monsanto Company St. Louis, MO, Analytical Sciences Center (ASC) 1978-1999 Analytical Research Chemist II 07/1997 to 09/1999
Provided Thermal Analysis and Physical Chemistry studies needed to support Company’s Strategic Business Units. Revised SOP’s and assisted in lab audits.
Analytical Senior Research Technician 04/1992 to 07/1997Provided Thermal Analysis and Physical Chemistry studies needed to support Bio- and Chemical technology. Trained new equipment users and supervised a summer student.
Analytical Research Technician III 07/1983 to 04/1992Performed various routine and complex Differential Scanning Calorimeter (DSC) and Thermal Analyzer (TA) analyses in support of clients’ projects.
Analytical Research Technician I 12/1978 to 07/1983Performed different sample digestion techniques for inorganic analyses (Atomic Absorption (AA) analyses, ICAP analyses and Colorimetric analyses).
EducationSt. Louis Community College at Florissant Valley
Associate in Applied Science
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