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Jorge A

Clinical Quality Assurance - 15 Years of Experience - Near 33175

Occupation:

Admissions Director

Location:

Miami, FL

Education Level:

Bachelor

Will Relocate:

YES

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Qualifications Summary Exceptionally organized, detail-oriented, and outcome-focused professional, aiming to pursue a career opportunity that would require exceptional competencies in research, program development, and biological sciences. Enthusiastic to apply extensive research, critical thinking, and communication skills in a variety of scientific and research functions within the biotechnology environments. Versatile individual with the ability to work independently or as part of a team while juggling multiple tasks. Well-versed in English and Spanish languages. Scientifically proficient with tissue culture, molecular biology, and flow cytometry method.

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Highlights:

Awarded for my outstanding contribution on the Navios Flow Cytometer 510 (k) Used my IVD reagent development knowledge to troubleshoot Quality Assurance complaint matters. Complete and average of 5-15 investigations per week. Trained in DID3 software. Trained on AQUIOS, CytoFLEX, Act Diff, and Act Diff 2 Software/Application.

Companies I like:

Becton Dickinson, Amgen, Beckman Coulter

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Knowledgeable with the CAPA process as well as the Field Action process. Complete Type 1 for MDR investigations < 19 days from date of awareness on a monthly basis. Stretch goal: Completion of 100% of AEs <15 days from date of awareness on a monthly basis. • Complete Type 1 investigations for the Czech Republic, Australia, Canada and European Union (EU) in < 10 days from date of awareness on a monthly basis. Stretch goal: Completion of 100% of AEs <7 days from date of awareness on a monthly basis. • Identify and communicate within 2 days changes that could affect Reportability decisions for AE investigations. Initiate CF action for AE team review for potential supplemental reporting. b. Type 2 • Complete Type 2 investigations in less than 35 days average on a monthly basis. Stretch goal: Complete CF investigations in less than 25 days on a monthly basis. • Assess Type 2 CF information and Oracle Report within 5 business days of CF assignment and reclassify and complete to Type 1, if necessary, within the timeframe established for Type 1 investigations. c. Backlog • Maintaining individual backlog >60 Days less than <4.0%, on a monthly basis, with a monthly rationale to manager if above 4.0%. Stretch Goal: Maintaining individual backlog >60 Days less than <2.0%, on a monthly basis. Exception for
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