Quality Assurance Project Manager
Resume:
Alicia Jeanveau
Hamilton, Ontario, Canada
********@*************.**
Quality Assurance Associate with 10 years of professional experience encompassing manufacturing, quality control testing, laboratory management and quality assurance roles in highly regulated environments (ISO, GMP). Experienced critical thinker with experience in the implementation of Quality Management Systems, to ensure compliance with Health Canada and FDA regulatory guidance.
SUMMARY OF SKILLS AND QUALIFICATIONS Strong communication and interpersonal skills, which have led to the successful development of relationships with internal and external business partners Well versed in GMP/GCP/ICH QMS Keen eye for detail, which has positioned me as key resource in product/systems surveillance Broad background in critical appraisal of scientific literature Effective time management exemplified by consistently meeting project deadlines while managing several competing priorities Proficient in software applications including Microsoft Word, Excel and PowerPoint
RELATED EXPERIENCE
Centre for Probe Development and Commercialization
Compliance Officer/Quality Assurance Associate February 2010-PresentInterface between Regulatory Affairs, Product Development and Quality and Manufacturing groups to ensure compliance of regulated activities in accordance with current regulatory requirementsResponsible for implementation of Quality Management Systems aligning corporate policy with relevant regulatory complianceWriting/Review of controlled documents in support of Quality Assurance/Regulatory Affairs to ensure compliance with applicable regulatory guidanceDevelopment and implementation of training programs for staff involved in all regulated activities Management of change control system including risk assessment, implementation, and support for regulatory notifications as requiredOn-going surveillance of regulated manufacturing facilities including co-ordination and support for internal/external audits as well as preparation of the Annual Notification.Direct experience in the preparation and review of quality documents in support of regulatory submissions to Health Canada/FDA for approval: SNDS, ANDA, NC, AN, CTA
Valliant Research Group, McMaster University
Laboratory Manager (Maternity Leave Replacement) May 2009-February 2010Responsible for managing day-to-day laboratory operations for graduate level laboratory including physical and human resources. Preparation of manuscripts and grant submissions Project Management role including co-ordination of meetings/teleconferences, budgeting and reporting to collaborators and external funding sources
Lantheus Medical Imaging (formerly Bristol-Myers Squibb), Hamilton, ON.
Radiation Safety Officer/Senior Laboratory Technician May 2005-May 2009 Responsible for the production, release and distribution of radio-labeled pharmaceuticals to fill customer prescriptions for medical imaging products in compliance with Master Formulae and Standard Operating Procedures (SOPs). Develop and maintain SOPs to ensure departmental compliance with Good Manufacturing Practices and Transport Canada and Canadian Nuclear Safety Commission regulations. Administrative functions including hiring and training of new staff, development of training programs in the areas of Environmental Health and Safety and Radiation Safety, inventory tracking and generation of records and reports.Perform internal audits and facilitate government audits to ensure compliance with radiation safety regulations and practices. Quality assurance including visual release of pharmaceutical cold kits and radio-labeled drug products, chemical and microbiological testing of compounded drugs as well as environmental monitoring, instrument calibration and validation.
American Society of Brewing Chemists, London, ON
Subcommittee Chair, New and Alternative Methods of Analysis May 2003-May 2005 Project Manager for the investigation of an alternative method of analysis for the detection of protein in hopped wort and beer. Responsible for recruitment of collaborators, coordination of samples, chemical analysis, statistical analysis and publication of results.
Labatt InBev, London, ON.
Analytical Chemist, Global Innovation and Development March 2003-May 2005 Responsible for the management of the analytical laboratory within the Chemistry group including ordering of instrumentation and consumables, hiring and training of new staff and project administration. Investigation and validation of new instrumentation and alternative methods of analysis. Provided analytical support for process and product innovation initiatives in the areas of Brewing, Packaging, New Product Development, Sensory, Chemistry and Microbiology. Advanced global support role, including instrument calibration, maintenance and repair, method validation, co-ordination of samples, analyses, advanced troubleshooting and compilation of data for brand profiling and quality tracking.
Agriculture and Agri-Food Canada, London, ON.
Analytical Chemist December 2002-March 2003 Responsible for HPLC/GCMS method development as well as interpretation and presentation of results.
Johnson Diversey Canada. London, ON.
Quality Control Chemist July-November 2002 Wet chemical, analytical and microbiological testing of consumer products to ensure compliance with Quality Control, ISO and GMP specifications.
EDUCATION
The University of Western Ontario, London, ON.
Bachelor of Science, Chemistry and Biochemistry Graduated October 2002
McMaster University, Hamilton, ON
Certified Clinical Research Associate Graduated June 2010
PROFESSIONAL AFFILIATIONS
Pharmaceutical Sciences Group Member Since November 2011
Parenteral Drug Association Member Since June 2010
Association of Clinical Research Professionals (ACRP) Member Since February 2010
Society of Clinical Research Professionals (SoCRA) Member Since February 2010
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