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Quality Assurance, Manufacturing, Compliance, Materials

Location:
Ponce, Puerto Rico
Posted:
March 19, 2014

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Resume:

787-***-****

***********@*****.***

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

Page 2

Director, Global Launch Operations at Pfizer, Inc

484-***-**** / 267-***-****

Margarita Colon

Quality Assurance Manager Pfizer OTC

787-***-**** X-6147

Jorge Cabrera

Quality Associate Director Pfizer OTC

299-***-**** / 787-***-****

Yadira Torres

Quality Assurance Supervisor II Pfizer OTC

787-***-**** X-6605

Page 3



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