Continuous Improvement Puerto Rico
Resume:
JUAN J. MORALES RÍOS
PO Box ****, Fajardo, PR *0738
Exceptionally bright biologist armed with advanced certification directly applicable to the pharmaceutical, federal wildlife
scientific research and laboratory setting. A leadership-by-example approach that includes integrity, high standards, and
strong work ethic. Proven ability to drive positive results, meet goals, communicate with diverse individuals on many levels
and to secure the trust, understanding, and confidence of clients and staff. Adept communicator; bilingual/biliterate in
English and Spanish
Validation Skillset: Bearer of formal academic credentials in Marine Biology, Minor in Ornithology, Ichtiology and Wildlife
Management. Solid training and certification in cGMP and Industrial Validation covering IQ, OQ, and PQ Protocol
Development, Risk Analysis, Disposition and Validation Documentation Processes to meet FDA requirements within the
pharmaceutical, and biologic industry. Learned in modern laboratory techniques, tools and processes, aseptic processes,
SOPs, regulatory provisions, and safety measures. Proficient performing and validating processes.
MANUFACTURING LEADERSHIP – Strong track record of functional management experience in various disciplines of biologic
manufacturing – Formulation, Fill, QC, Disposition, Validation and Analytical Sciences Developing and revising SOPs,
validation protocols and improving operating procedures Establishing goals and performance metrics.
CONTINUOUS IMPROVEMENT & TRAINING – Designing and facilitating training programs for team leaders and team
associates Drafting training materials for CIP, SIP, validation, and equipment assembly.
EXPERIENCE
JUAN MORALES MARINE BIOLOGIST PROFESSIONAL, Fajardo, PR 1989-Present
Recognized, as the only Scientific Research Specialist bearer of Marine Biology, Ornithology, Ichtiology and Wildlife
Management degree. Plan, direct and hold ownership of Puerto Rico, US Agriculture, Forest Service and US Fish & Wildlife
Federal Agencies projects and recognized as subject matter expert for scientific research and projects on per diem basis for
Archaeological Excavation Projects, and Ornithology Projects.
Contracted by the United States Forest Service an agency of the U.S. Department of Agriculture to serve as
Resource’s advisors to perform scientific research for the endangered species of orchid Lepantes eloroensis
endemic to El Yunque National Forest in Puerto Rico and mitigate land damages due to Hurricane Maria’s
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Contracted by PR Natural Resources Department to perform Benthic ecology study for special events regarding
movie filming and construction plans for new Marinas and water ramps.
ECO ACTION TOURS, Fajardo, PR
Biologist & Guide
2021-Present
Provide biological tourism using kayak to paddle along the mangrove channels to Laguna Grande, to admire the
bioluminescent water a unique natural phenomenon is caused by tiny organisms called dinoflagellates.
AMGEN MANUFACTURING LIMITED - Juncos, PR 9/2015-1/2017 7/2020-1/2021
“World’s Leading company’s primary commercial formulation, fill and finish biologics manufacturing plant producing
Eupogen, Neupogen, and Prolia for worldwide distribution.”
during Laboratory assistant role previously. Formed part of QA team reviewing and approving manufacturing processes,
non-conformance, and change control documents to validate the final release. Conducted visual inspection of in-process
products according to company procedures. Participated in Media Fill Certifications and provided quality support during the
Airflow Visualization Studies (Smoke Test) for Filling Line Isolators. Reviewed and approved of logbooks and manufacturing
orders (MO) to comply with EBR and SOP’s and GMP’s. Assure quality procedures during Isolators (Syringe and Vials)
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Chosen by Supervisor to serve as interim manager to oversee full manufacturing process and training peers in
quality Control standards.
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Inspected and audited State of the Art equipment’s
comply
with operational
parameters
and FDA
Participated during Mis netting events to capture individuals for different types of data gathering. Directed the first capti ve
bird release to the wild using radio transmitters and triangulation. Conducted public speaking presentations and
orientations school groups and public.
isolators, and autoclaves. Documented using LIMS B2B and SAP. Sterilized materials, culture media and equipment to be
used at aseptic area for stability test. Prepared in house media culture, sanitizers and glass ware used for testing.
Performed maintenance and set up QC Sterility Laboratory testing area and equipment for ongoing and upcoming essays
and experiments. Prepared monthly external environmental air sampling around Piperacillin facilities to detect Penicillin
contamination.
FEDERAL SCEINTIFIC RESEARCH PROEJCTS
remains; Roosevelt Roads land.
PUBLICATIONS
Juan P.R
“Memory of the Humacao Ornithology Symposium”, Author of the “Caribbean Ornithology Symposium”, Humacao, PR, 1999
“Feeding Habits of the Crowned Night Heron”, 1990
SCIENTIFIC RESEARCHERS OF THE NATURAL RESOURCES DEPARTMENT
Humacao Chapter, President
Member
Assisted DRN scientist in scientific projects and worked at Caja de Muertos Island Natural reserve as interpretative
tourists guides.
Recognition for his valuable contribution, 1996
Outstanding Service as President, 1985
PUERTO RICO POLICE ATHLETIC LEAGUE
Drill team Member
COMMUNITY ENGAGEMENT
“Limpieza Internacional de Costas”, 1993-2004 Volunteered for several years on a local Coastal Cleanup, impacted East
PONCE EARTHQUAKE Contributed to Ponce’s earthquake survivors mental and psychical wellness by distributing food and
EDUCATION
Bachelor’s Degree Marine Biology, Minor in Ornithology, Ichtiology and Wildlife Management (Cum Laude)
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OSHA 300, Job Hazard Analysis
Occupational Safety
Ergonomic Management
Total Qualities (GMP)
Environmental and Health Service
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Safety Equipment.
B2B, SAP user
Solidworks Essentials
3D printing
ICs100 & ICs 700
QUALITY CONTROL SPECIALIST
Rejoined Puerto Rico’s and the Caribbean leading pharmaceutical to serve as QC specialist after outstanding performance
Representative Projects:
*******@*****.***
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devastation.
Validation Process. Monitored and audited routine and non-routine intervention and mechanical interventions during
aseptic filling process and document the activities and document in EBR.
PUERTO RICO DEPARTMENT OF NATURAL AND ENVIRONMENTAL RESOURCES, San Juan, PR 1988-1995
Biologist
Contracted by the US Fish and Wildlife Service Agency to form part of a selective scientific group to perform research of
ASSOCIATIONS
“1992 Annual Meeting of the Society of Caribbean Ornithology”, EL CONVENTO HOTEL OLD SAN JUAN, PUERTO RICO, 31 JULY -5
ARCHAELOGY PROJECT- Leveraged Ornithology, Ichtiology and Wildlife Management expertise to collaborate in several
archaeology excavation project: crescent Cove-Palmas del Mar due to the discovery of “Pre-Taino” an indigenous civilization
Pfizer, (Wyeth) Carolina, Puerto Rico 1999-2010
Laboratory Assistant
Commissioned to lead Media Field schedules and concurrently work at laboratory to review, approve media and equipment
preparation and sterilization batch record and equipment’s recorded charts and cycle print outs for incubators, refrigerator,
them management of captive endangered species Puertorrican Plain Pigeon (Columba inornata wetmorei) “Paloma
Sabanera” population. Monitored bird feeding and medication process. Performed seasonal wild populations census.
Handpicked to draft and submit sensitive-critical Quality documentation to certify that process were in full
compliance with FDA’, GMP’s and ISO9001 standards using SAP and Electronic Batch Records.
CICA, CUERPO DE INVESTIGADORES CIENTIFICAS AUXILIARES DEL DEPARTAMENTO RECURSOS NATURALES AUXILIARY
AUGUST 1992
“First release of PUERTO RICAN PLAIN PIGEONS”, Columba Inornata Wetmorei, Coauthor Departmen of Natural Resources, San
Led investigations, internal plant, and site audits; generated a number of validation ad laboratory reports.
Held ownership of formulation, Dispensing and Filling process to secure process optimal completion.
One of the few to audit critical areas sanitation and assure adherence to GMPs, SOPs and EHS.
Drove efficiencies and fixed high incidence of formulation failures of biologics due to staff non-conformance.
Promoting a continuous improvement culture, established and currently facilitate weekly team meetings and
training sessions discussing production plans and SOP’s Addressing process-related doubts. Participated in Media
Fill Certifications of Vials and Syringe production area.
to assure that
regulations.
UNIVERSITY OF PUERTO RICO, Humacao Campus, PR
Region beaches (Seven Seas, Las Croabas).
emergency kit.
Awarded with Leadership and Cooperation Certificate
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