Deborah Gonzalez
Senior Qa Product Manager @Lonza
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WORK HISTORY
Senior Qa Product Manager @Lonza
Tampa, FL, US
Oversee customer product/programs. Dedicated customer advocate and SME throughout the product lifecycle. Liaison between internal teams, service providers and customers to ensure accurate and timely communications, expert troubleshooting, and ensure on-time delivery.
EDUCATION
Interamerican Univers Guayama Campus
BS, Biology; Pre-Medical Technology
Interamerican Univers Metropolitan Campus
Post-BS Degree, Medical Technology
ABOUT DEBORAH GONZALEZ
Quality Senior, with comprehensive experience in Regulatory Compliance/Quality Assurance/Quality Systems/Quality Control/Project Management in manufacturing environments within Pharmaceutical, Medical Device and Biotechnology Industries. Major strengths in Investigations/Root cause analysis/CAPA/Auditing/Technical writing/Training/Change control/Validation/Cleaning Validation/Documentation/Batch Record/Standard operational procedures/Production Process/ Instrumentation/Incoming/Microbiology testing/Environmental monitoring and Sterilization processes (EtO and Gamma). Proficient in Regulatory Compliance, Quality systems, cGMP, FDA, cGLP, ISO, OSHA, Gap analysis, Product Risk Management, among others. Strong leadership skills, a high level of adaptability, with an analytical mind to solve complex quality issues. Ability to promote and maintain a high level of Quality Competence, motivation to accomplish objectives and meet deadlines. Fully bilingual (Spanish/English) and proficient in computerized systems such as: MS office, TrackWise System, Oracle (Agile/PLM), SAP, Compliance Wire and LIMS.Specialties: Investigations, Quality Assurance, Gap analysis and Auditing. Medical Devices, Pharmaceuticals and Biotechnology.
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