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Redesigned the Quality Systems of a Biologics company as a result of an FDA Warning Letter. This
project resulted in a compliant Quality System and ensured no further regulatory action.
J
ANE
W
EITZEL
P
AGE
T
WO
Achieved registration to ISO 9001 at a pharmaceutical company in one year. This gave the company a
competitive advantage and demonstrated the Quality Systems met the current standard.
WORK HISTORY
JANE WEITZEL CONSUTANT
, Winnipeg, Manitoba
2000 – Present
Consultant
Consulted and trained on lab Quality Systems, both cGMP and ISO 17025, with specialization on Method
Validation and the estimation and use of Measurement Uncertainty. Clients represent many industries including
mining, pharmaceutical, environmental, food testing, etc. In all cases, the labs achieved ISO 17025 accreditation
on the first audit enabling them to attract new business and meet requirements of both their customers and
regulatory bodies.
Assessor A2LA
Auditor for Standards Council of Canada
QUALITY ASSURANCE PERSON FOR MEDICAL MARIHUANA COMPANY
2014 - Present
Responsible for all Quality Assurance Person duties regarding growing and selling medical marihuana in Canada
according to the Marihuana for Medical Purposes Regulations (MMPR).
VALEANT PHARMACEUTICALS INTERNATIONAL
, Steinbach, Manitoba
2010 – 2011
Director, Laboratory Services
Responsible for all activities of lab with over 70 staff to support commercial drug manufacturing, including method
development, validation and routine QC testing, equipment qualification, calibration and maintenance. Also
responsible for the stability program and the Annual Product Review. Managed the lab budget of over $5M.
Implemented use of Measurement Uncertainty which identified opportunity to reduce costs by $50K per
month and reduce testing by 25%.
Reorganized lab documentation system and introduced use of lab worksheets with real time data review
which is expected to reduce test turnaround time by 30%.
WATSON LABORATORIES
2005 – 2010
Associate Director, Laboratory Operations
, Corona, California
2007 – 2010
Responsible for remediation activities in response to Consent Decree. Handled all method development,
validation, and transfer as well as all document control for the Lab. Oversaw Instrumentation Purchase,
Qualification and Maintenance and annual budget of over $4M.
Quality Assurance Manager
, Salt Lake City, Utah
2005 – 2007
Responsible for Quality Assurance in the commercial and development transdermal manufacture plants and in
the analytical labs
Oversaw the lot release program and redesigned the investigation process to eliminate delays in lot releases.
Improved the efficiency and effectiveness of the QA systems, by implementing a process audit program and
streamlining the Batch Record Release process.
Reorganized the Quality Assurance department along function to improve GMP compliance and efficiency.
Mentored and developed staff resulting in people being promoted internally to supervisory positions.
CANGENE CORPORATION
, Winnipeg, Manitoba
1997 – 2005
Quality Assurance Manager
2000 – 2005
Responsible for cGMP and ISO 9001 Quality Systems in the plasma collection facilities around North America,
and the plasma fractionation Manufacturing facility, including the aseptic filling line, contract manufacturing.
AOAC OMB Meeting Book
109