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MARIA I SANTANA COLON
Urb. Villa Forestal Buzon 413 Manati, P.R. 00674 • Cell: (787) 598-0839
E Mail: santana197635@yahoo.com
PROFILE
A coordinator and audit level in pharmaceutical industry, with extensive
experience in, quality assurance and responsible for a number of creative, cost
effective solution to business problems of pharmaceutical operations. My ability
to analyze and conceptualize, manage multiple priorities, set goals and meet
deadlines, while development an efficient and motivated staff has been key to my
success and that for my company.
PROFICIENCIES:
 Lean Six Sigma Methodology implementation
 Productivity improvement
 Development and Validation/ Cleaning Validation of new products test method
 Generate protocols and validation report
 Performing and closing of investigation
 Standard Operating Procedures development
 Audit raw material, packaging components and finish product
 Coordinate Incoming activities
 Activation of procedure, Master Batch Records and Specifications
 Performed department metrics
 Participate in Clients audits and Company diagnostic
MAJOR ACCOMPLISHMENTS:
 Led a team that improved audit process of the main product by means of Lean
Manufacturing thecniques.
 Managed the improvement and reduce audit time frame by means of Lean
Manufacturing techniques.
 Developed metrics and established goals to help the plant in focusing their
attention in the most critical aspects of the operation: quality, compliance, safety
and productivity.

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 Executed investigations of complex deviations to assure real root cause
determination to provide corrective and preventive actions that truly avoid
recurrence.
 Revised several SOP's, originally developed for compliance with Consent Decree
with the FDA, in order to flexibilize them to be more productive but in compliance
with the agency's exigencies.
PROFESSIONAL EXPERIENCE
February 2008 to Present, Patheon, Inc. (Formerly MOVA), Manati, PR
CSV/C
QA Auditor
Patheon Advantage project development for Quality Assurance and Quality Control
departments
February 2004 to January 2008, Patheon (MOVA), Manati, PR
QA Incoming Coordinator
May 2003 to December 2004, J. Alifonso and Associates, assigned at Shering-
Plough L.L.C., Manati Operation during Consent Decree
Specialist Consultant at Chemical Plant and Quality Control laboratory
August 1999 to May 2003, Patheon (MOVA) Caguas, P.R. Research and
Development Center (R&D)
Analytical Services Analyst /Auditor
EDUCATION and TRAINING:
University of Puerto Rico- Humacao Campus, BS Major in Industrial Chemistry-
Cum Laude (December 1999)
Certified Quality Auditor (CQA)
Acceptance Sampling and ANSI/ASQ Z1.4-2003
Green Belt
Looking forward Black Belt training and Certification (process)