Accepted a position in January 2010 as Quality Assurance Officer for A&B Labs. Environmental and Industrial Hygiene with some HACCP work and a custom LIMS being marketed to both environmental & pharma labs.
Seeking to apply more than 18 years of experience in the administration and orchestration of quality assurance platforms to a pharmaceutical organization such as yours, I include my resume for your consideration. For any provider of consumer products / services, the delivery of top quality offerings is a top priority. Having served an instrumental role in ensuring the above, I offer a strong portfolio of successes encompassing continuous quality improvements, top team building / direction, SOP optimization, regulatory compliance, and audit operations.
During the course of my career, I:
• Was successful in the orchestration of audits, peer reviews, corrective / preventive action planning, QC data reviews / analysis, and staff training (quality control, safety, ethics, etc.).
• Facilitated identification and troubleshooting of quality issues, introducing traceability procedures / action plans.
• Increased client satisfaction through cultivation of productive relationships.
• Maintained lab certifications and secured accreditations (encompassing compliance with ISO 9001 regulations).
• Elevated laboratory safety and performance with the introduction of manuals, informative meetings, and training.
• Impacted lab productivity with the creation and revisions of SOPs and root cause analysis strategies.
• Generated annual savings by identifying that there was no need for specific radiation licenses for equipment.
• Ensured high levels of data accuracy within reports, laboratory documentation, and manuals.
• Secured ISO 17025 Accreditations (3 times) and NELAC Accreditation (3 times), achieving successful transition.
• Slashed expenditures through SOP revisions.
• Pioneered creation and provided enforcement of unambiguous traceability procedures.
• Enhanced document management system with the establishment of highly effective control techniques.
In addition to the above, my offerings also include extensive studies in the areas of Quality Assurance and Regulatory Affairs in the Pharmaceutical Industry as well as advanced academics culminating in a Master of Science degree in Biology. Please feel free to contact me to discuss specific ways I can contribute to your company’s success. Thank you in advance for your consideration.
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Quality Assurance Intern
KRC, Inc.
This was a comprehensive internship that included work as a QA Trainor, a Formulary Consultant, a Technical Writer, a QA Documentation Associate, and a Compliance Auditor.
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Sep 2004 - Oct 2008
houston, TX (US)
QA Supervisor & Safety Manager
SouthWest Environmental Labs
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2008 - 2009
Other
- GLP. GCP, GMP
KRC, Inc.
This was an online training course "Quality Assurance & Regulatory Affairs ICH GLP, GCP, GMP Program". While located out of Canada, this course contained mostly FDA regulations with some TPD regulations.
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1985 - 1990
Master's
- Biology
University of Houston
"Quality Assurance and Regulatory Affairs in Pharmaceutical Industry" ICH GCP, GMP, GLP from Kriger Research Center. Received January 2009
American Association of Pharmaceutical Scientists (AAPS)
International BioPharmaceutical Association (IBPA)