***********@*****.***
camille olivieri
OBJECTIVE Work for a company where I could develop the skills and knowledge I have learned and acquire
through years of studies and experience, and a company where my qualifications and
experiences will match. I want to achieve a successful career in a progressive organization
offering advanced opportunities and personal growth.
SKILLS & Bilingual (fluent in English and Spanish), responsible, leadership skills, and initiative to work,
well organize and able to work under minimum supervision, capability to work either
ABILITIES
independently or as a member of a team, quick study and eager to learn new things, analytical
mind, strong mathematical and writing skills, computer knowledge, committed to quality
service.
RAW MATERIAL QUALITY SPECIALIST
EXPERIENCE
Dec 2012 – May 2013 Business Excellence Consulting at Mylan Pharmaceuticals, Caguas, PR
FDA observations remediate project. Raw materials and Packaging components audit and
disposition. Expired raw materials, packaging components and finish product rejection project
owner. Trackwise rejection initiator. Incident Report Writing. Deviation report writing
experience. Records audit for compliance, completeness and correctness according with the
Federal Drugs Administration (FDA) Regulations, 21 Code of Federal Regulations, Parts 210
and 211. Annual Product Review. Laboratory tests results analysis and documentation evaluation
prior disposition. GDP and GMP revision support activity of Master Batch Records.
QUALITY SPECIALIST
October 2010 – Nov 2012 Pfizer Pharmaceuticals OTC, Guayama
Responsible for Manufacturing, Packaging and Storage areas. Manufacturing area process audit
and product disposition. Manufacturing leaders advisor, make necessary arrangements to correct
any deviation during manufacturing process. Implementation of In Line Review for
manufacturing area. Deviation report writing experience. Support in the evaluation of MIR,
Change Controls and Commitments. Quarantine approval and quarantine removal. Production
Master Batch Record Audit for compliance, completeness and correctness according with the
Federal Drugs Administration (FDA) Regulations, 21 Code of Federal Regulations, Parts 210
and 211. GDP and GMP revision support activity of Master Batch Records. Use of
Manufacturing Execution System (MES), SAP, Labware and SMS-SQ. Quality Specialist 3rd
shift leader. Raw Material and Packaging Components audit and disposition. Laboratory tests
results analysis and Documentation evaluation prior disposition.
QUALITY SPECIALIST
October 2006 – May 2008 Wyeth Pharmaceuticals, Guayama
Quality Specialist- Master Batch Record Audit for compliance, completeness and correctness
according with the Federal Drugs Administration (FDA) Regulations, 21 Code of Federal
Regulations, Parts 210 and 211. GDP and GMP revision support activity of Master Batch
Records. Manufacturing leaders advisor make necessary arrangements to correct any deviation
during manufacturing process. Shop Floor Excellence Team member. Hudle Team member.
Support in the evaluation of MIR, Change Controls and Commitments. Use of Manufacturing
Execution System (MES), SAP, Labware and Trackwise.
MICROBIOLOGIST VALIDATION PROJECT
May 2006 – September 2006 ReComs Regulatory Compliance
Services (ReComs Laboratory, Humacao)
Microbiology Test Methods Validation for Cordis, San German. Knowledge in Growth
promotion, viable spore count of biological indicators, microbial isolation, microbial water
sampling & testing membrane filtration, surface and air monitoring, inoculums verification,
gown monitoring, swab testing.
THIRD PARTY CERTIFICATE
August 2005 – May 2006 ReComs Regulatory Compliance
Services (Cordis LLC San German, PR)
Master Batch Record Audit and certification according with the Federal Drugs Administration
(FDA) Regulations, 21 Code of Federal Regulations, Parts 210 and 211. Batch Record Audit for
completeness and correctness, and have knowledge of Good Documentation Practices, Good
Laboratory Practices, and Standard Operating Procedures.
QUALITY ASSOCIATE
Feb 2004 - July 2005 Ocular Sciences Caribbean, Juana Diaz
Metrology laboratory and Metrology Quality Assurance.
Perform confidential research for quality improvement purpose and also perform Clinical
Studies. Work with stereoscopes, micrometers gauges, calipers, calibrations and documentation.
I also worked with the Quality Department making research of a new product for quality
improvement purpose. Production Quality Associate.
INTERAMERICAN UNIV. OF P.R, PONCE BACHELOR DEGREE B.S. BIOLOGY S.S.
EDUCATION
MICROBIOLOGY
OSHA Regulations (40 hrs.)
Analytical Test Method Validation Certification (24 hrs.)
CQA Training (24 hrs.)
REFERENCES Miguel Cacho
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Director, Global Launch Operations at Pfizer, Inc
Margarita Colon
Quality Assurance Manager Pfizer OTC
787-***-**** X-6147
Jorge Cabrera
Quality Associate Director Pfizer OTC
Yadira Torres
Quality Assurance Supervisor II Pfizer OTC
787-***-**** X-6605
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