1. Deborah A. Johnson
Phone: (314) 435-0248 // E-mail: daj22@sbcglobal.net
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).
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
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2. Deborah A. Johnson
Phone: (314) 435-0248 // E-mail: daj22@sbcglobal.net
safety training for new and existing employees.
• Performed internal audits of facilities, processes and work practices for Safety
Program compliance.
• 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 09/2007
Ensured 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 07/1997
Provided 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 04/1992
Performed 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 07/1983
Performed different sample digestion techniques for inorganic analyses (Atomic
Absorption (AA) analyses, ICAP analyses and Colorimetric analyses).
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3. Deborah A. Johnson
Phone: (314) 435-0248 // E-mail: daj22@sbcglobal.net
Education
St. Louis Community College at Florissant Valley
Associate in Applied Science
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