Quality Assurance Training
Resume:
Colleen L. Colson
Cincinnati, OH 45248
Career Summary
Cincinnati Children’s Hospital Cancer and Blood Diseases Institute January 2009 - Present
•
Quality Assurance Conduct audits of clinical trial activities to ensure trials are conducted in
Coordinator compliance with the protocol, SOPs, ICH GCP, and FDA regulatory requirements.
(GCP)
• Led the team that developed process maps for documentation and reporting of
deviations and writing notes to file. Developed training sessions for the process.
• Led the team that wrote, revised and implemented 28 SOPs in 6 months.
• Developed and implemented a quality review process to define risk levels
associated with review findings, and associating higher risk level findings with a
regulation, guidance, protocol or SOP requirement.
• Developed and implemented a system for maintaining investigator files in an
electronic format eliminating duplicate paper records.
• Developed and implemented an electronic system to document and track the
reading and understanding of SOPs.
• Developed and implemented a financial record auditing program.
• Developed curriculum for training sessions including Good Documentation
Practices for GCP and FDA Inspection Readiness Training.
Procter & Gamble Pharmaceuticals November 1989 – November 2008
•
Quality Led efforts in developing GLP compliant systems for Bioanalytical and Safety
Assurance Pharmacology.
Auditor (GLP)
• Led computer system validation teams that streamlined the validation process for
infrastructure qualification and software validation.
2001 - 2008
• Developed curriculum for training sessions including Introductory GLP Training,
GLP Documentation Training, and Computer Validation Training.
• Member of the SOP team that completely revised the SOPs which increased
efficiency and regulatory compliance.
• Simplified procedures and increased regulatory compliance for instrument
qualification.
• Audited internal and external non-clinical Toxicology, Safety Pharmacology, and
Pharmacokinetics studies. This included in-life, facility, equipment, final report and
contributing scientist report audits.
•Served as Study Director for General Toxicology GLP and non-GLP studies.
Study Director
2000 - 2001
•Functionally managed a group of five Study Coordinators executing non-clinical
General
Toxicology Group Toxicology studies.
Leader
•Established a fully functioning GLP compliant toxicology group in four months.
•Developed a Study Coordinator training program that built standardized systems
1998 - 2001
and increased efficiencies.
Professional Development
Registered Quality Assurance Professional: RQAP-GLP, RQAP-GCP
Colleen L. Colson – Page 2
Certified Laboratory Animal Technologist (LATG)
Member of the Society of Quality Assurance
Education
AAS, Veterinary Science, State University of New York - Delhi, 1989
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