Juan J. Morales Ríos

PO Box **** Fajardo, Puerto Rico 00738

787-***-****

adj6wv@r.postjobfree.com

Summary of Qualifications

● A Fourteen (14) years of professional experience in the Pharmaceutical Industry working in the Quality Control and Quality Assurance areas.

● Experience working in a regulated environment; knowledge of GMPs, GDPs, and GLPs

● Experience in Track Wise, SAP, EDM (Electronic Document Management), EBR (Electronic Batch Record), and LIMS (Laboratory Information Management System) applications.

● Excellent interpersonal skills, bilingual (Spanish and English), and good team leader skills to help keep a positive environment.

● Delivers results and achieves professional goals.

● Ability to work on multiple tasks, well organized and skilled in setting priorities. Attention to detail concerned with quality, aseptic techniques, documentation, cGMP and Media fill. Skills. Skills

Responsible, hardworking, punctual, honest and high level of initiative. Ability to work under pressure, paying close attention to details with minimal supervision. Demonstrates ability to solve complex issues and accept responsibility for actions and decisions. Professional Experience

AMGEN Manufacturing Limited Juncos PR

QA Specialist (contractor worker) 07/21/2020- 01/15/2021

• Perform and document manufacturing areas oversight of aseptic filling operations to assure compliance with current process and procedures.

• Conducting oversight of aseptic techniques and adherence to procedures.

• Audit product filling lines (vials & syringes) set-up process to assure that equipment is assemble following procedures step by step.

• Monitor and audit routine and non-routine intervention and mechanical interventions during aseptic filling process and document the activities and document in EBR.

• Evaluate and document that the staff is following the written procedures, including the proper documentation.

• Audit critical areas sanitation and assure adherence to GMPs, SOPs and EHS.

• Observe, correct and discuss any deviation to procedures (SOPs & GMPs) with staff members involved and notify to supervisor the actions taken.

• Review and approval of logbooks.

• Participated in Media Fill Certifications of Vials and Syringe production area.

• Audit equipment’s to assure that comply with operational parameters and FDA regulations. FEMA for Forest Service Maria Incident, Rio Grande PR 01/16/2018 - 02/02/2018 Resource Advisor

• Resource Advisor for endangered species as birds, snakes and little tiny plants at El Yunque Forest.

• Search and document presence of endangered species as the unique tiny orchid Lepantes eltoroensis.

• Mark with flagging areas or substratum were the organism was present.

• Document species, amount and position using sophisticated equipment.

• Write instructions to forest Firefighters to manage endangered species. AMGEN Manufacturing Limited Juncos PR

Juan J. Morales Ríos

PO Box 1590 Fajardo, Puerto Rico 00738

QA Specialist (contractor worker) 09/21/2015- 01/28/2017

• Perform and document manufacturing areas oversight of aseptic filling operations to assure compliance with current process and procedures.

• Conducting oversight of aseptic techniques and adherence to procedures.

• Audit product filling lines (vials & syringes) set-up process to assure that equipment is assemble following procedures step by step.

• Monitor and audit routine and non-routine intervention and mechanical interventions during aseptic filling process and document the activities and document in EBR.

• Evaluate and document that the staff is following the written procedures, including the proper documentation.

• Audit critical areas sanitation and assure adherence to GMPs, SOPs and EHS.

• Observe, correct and discuss any deviation to procedures (SOPs & GMPs) with staff members involved and notify to supervisor the actions taken.

• Review and approval of logbooks.

• Participated in Media Fill Certifications of Vials and Syringe production area.

• Audit equipment’s to assure that comply with operational parameters and FDA regulations. 787-***-****

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Pfizer, (Wyeth) Carolina, Puerto Rico Laboratory Assistant 04/26/1999 – 10/18/2010

• Review and approved media and equipment preparation and sterilization batch record.

• Review and approved equipment recorded charts and cycle print outs for incubators, refrigerators, Isolators and autoclaves.

• Prepared in house media culture, sanitizers and glass ware used for testing.

• Documented in LIMS B2B and SAP.

• Sterilized materials, culture media and equipment to be used at aseptic area for stability test.

• Responsible for maintenance and setting up QC Sterility Laboratory testing area and equipment for ongoing and upcoming essays and experiments.

• Responsible to perform monthly external environmental air sampling around Piperacillin facilities to detect Penicillin contamination.

• Sanitize and maintenance of Sterility aseptic area.

• Procurement for microbiology, environmental and stability department materials and equipment.

• Responsible for laboratory supplies and inventory.

• Create, update and review the SOP’s for new and old Laboratory equipment.

• Participated in laboratory validations by preparing equipment, materials and operating equipment’s

• Determining equipment critical loads of media and equipment.

• Responsible of equipment care and maintenance as incubators, refrigerators, ovens, autoclaves and laminar flow hoods.

• In charge of setting and operation of equipment during validations as thermocouples, bioindicators and Kaye.

• Management of hazardous and non-hazardous materials and validation used media fills.

• Provide support during Airflow Visualization Studies (Smoke Test) for aseptic rooms and Isolators.

• Freeze drier operator.

Juan J. Morales Ríos

PO Box 1590 Fajardo, Puerto Rico 00738

787-***-****

adj6wv@r.postjobfree.com

Natural Resources Department, San Juan, Puerto Rico 02/15/1988 – 10/16/1995 Biologist

• Management of captive endangered species Puertorrican Plain Pigeon (Columba inornata wetmorei)

“Paloma Sabanera” population.

• Prepared daily feeds and medication of birds.

• Managed the care of broods, squabs and nests.

• Conducted seasonal wild population’s census.

• Participated during Mis netting events to capture individuals for different types of data gathering.

• Directed the first captive bird release to the wild using radio transmitters and triangulation.

• Conducted public speaking presentations and orientations school groups and public. Education

University of Puerto Rico, Humacao Campus

Bachelor’s Degree Marine Biology, Minor in Ornithology, Ichtiology and Wild Life Management

(Cum Laude)

• OSHA 300, Job Hazard Analysis

• Occupational Safety

• Ergonomic Management

• Total Qualities (GMP)

• Environmental and Health Service

Juan J. Morales Ríos

PO Box 1590 Fajardo, Puerto Rico 00738

• Safety Equipment.

• B2B, SAP user

• Solidworks Essentials

• 3D printing

• ICs100 & ICs 700

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