Jeannette Aponte Ayala

Jeannette Ayala

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Jeannette Zelada Ayala

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Jeannette Ortiz Ayala Toa Alta, PR

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Work:

Medtronic

Apr 2013 to 2000
Sr. Compliance/Audit Specialist McNeil
Las Piedras, PR, US
Jan 2012 to Mar 2013
Consent Decree Quality System Element Lead McNeil, LP
Las Piedras, PR
May 2011 to Dec 2011
Investigation System Implementation Project McNeil, LP
Las Piedras, PR
Oct 2010 to May 2011
Sr. Stability Compliance Specialist McNeil, LP
Las Piedras, PR
Aug 2005 to Oct 2010
Senior Quality Assurance Specialist Pfizer
Vega Baja, PR
Aug 1997 to Aug 2005
QC Laboratory Chemical Analyst

Education:

University of Phoenix
Guaynabo, PR
2005 to 2007
Master in Business Administration with concentration in Technology Management Metropolitan University
San Juan, PR
2000 to 2002
Master - Completed all credits 4.0 GPO in Environmental Management University of Puerto Rico
Cayey, P.R., US
Bachelor in Chemistry

Skills:

RABQSA [] Lead Auditor Certification with auditing experience (Internal/External/Supplier). Experience in the regulated environment primarily focused in the Quality Assurance and Compliance areas. Knowledge in FDA regulations, cGMP, cGLP, USP, OSHA, EPA and RCRA. Ability to analyze scientific and technical data with knowledge in statistical analysis. Trained in Process Excellence/Six Sigma Tools. Strong technical writing skills. Knowledge in Process Failure Mode and Effects Analysis risk assessments. Experience as CAPA Systems Administrator in SAP, EtQ/Symphony and Trackwise. Computer literate in document and data management systems such as MS Word, Excel, Power Point, Minitab, Visio, LIMS, CALS and Agile. Self-starter and team-work oriented with excellent leader, negotiation, interpersonal and decision-making skills. Ability to manage multiple tasks. Fully Bilingual (Spanish and English) with good written and oral communication skills. Good interpretation skills in the handling of Quality issues.