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Sabrina V

Quality Engineer - 14 Years of Experience - Near 91016

Occupation:

Quality Manager

Location:

Azusa, CA

Education Level:

Bachelor

Will Relocate:

YES

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 Over14 years of in-depth experience in the pharmaceutical industry.  Highly analytical thinking with demonstrated talent for identifying, scrutinizing, improving, and streamlining complex work processes.  Experience in Quality Systems and Manufacturing Operations, Change Control, Process Validation, Documentation, Manufacturing and Maintenance systems utilizing cGMP, industry standards and lean manufacturing approaches.  Innovative problem-solver who can generate workable solutions and resolve complaints.  Flexible team player who thrives in environments requiring ability to effectively prioritize and juggle multiple projects.  Effective organizational, written communication, and reading comprehension skills.  Assist with execution of protocols.  Bilingual in Spanish.  (BPLM) Baxter Product Lifecycle Management, (EQMS) Enterprise Quality Management Solution TrackWise, (JDE) Edwards EnterpriseOne.  EPA QA/G-6 Standard Operating Procedure (SOP).  US FDA Title 21 CFR Part 820 Quality Systems Regulation.  US FDA Title 21 CFR Part 11 Part 11 Electronic Records, Electronic Signatures.  US FDA Title 21 CFR Parts 210/211 Good Manufacturing Practices.  21 CFR Parts 210/211 Drug GMPs.  21 CFR Part 820 Device GMPs.  ICH Q7 - GMPs for Active Pharmaceutical Ingredients.  Change Management (ERP).  International Organization for Standardization (ISO).  Validation of Process and System.  Hazard Analysis and Critical Control Points (HACCP).

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COMPANY POSITION HELD DATES WORKED

(Confidential) Independent Business Owner, Los ngeles Ca 1/2018 - Present
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SCHOOL MAJOR YEAR DEGREE

University of Phoenix - Pasadena Campus Business Administration 2010 Bachelor Degree
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