1. Emely Hernández Hilerio
(787) 546-0389 delfines_79@hotmail.com
Summary of Qualifications
Dynamic Quality Assurance professional with vast experience in the Pharmaceutical Industry and FDA
Regulations. Hands on experience in areas of Manufacturing and Quality Control. Knowledge in GMP Technical,
Consent Decree and documentation. Integrity, sense of urgency, encouraged by results and performance,
teamwork and adaptability. Excellent interpersonal and communication skills. Computer literacy in Microsoft
Office (Word, Excel, PowerPoint) and Internet. Bilingual English and Spanish.
Professional Experience
McNeil Healthcare, Las Piedras, Puerto Rico
QA Specialist-BRR Product Disposition / Quality Assurance Technician 2012 - 2016
• Prepared quality documentation and reports by collecting, analyzing and summarizing information.
• Compiled all records/documents and completes final batch record review.
• Confirmed batch record review includes all associate documents including checklist and calculated
metrics area as Right First Time.
• Executed all quality assurance activities related to review and approve GMP’s document such as Master
Products or Batch Records within MES System. Provided partial disposition in SAP for Packaging Area.
• Coordinated batch records inventory with Packaging Area.
• Assisted with the implementation of revisions, corrections and changes to test equipment, procedures and
methods.
• Validated quality processes by establishing product specifications and quality attributes; measuring
production; documenting evidence; determining operational and performance qualification; writing and
updating quality assurance procedures.
• Examined materials and parts from the supplier to ensure compliance with specifications.
• Completed record of inspection results, acceptance, rejection and disposition for entry into logbooks or
computer systems.
• Received and collated Retain Samples.
• Responsible for clearance verifications.
• Supported facilities and environmental activities. Supported Ergonomic and Safety Exercises.
• Trained new employee’s area.
Documentation Specialist 2010 – 2012
• Identified the packaging records that required the stability and microbiology samples.
• Filed and reconciliation of master packaging and manufacturing executed records.
• Transferred master packaging and manufacturing executed area to McNeil II.
• Created solutions orders, assigned effective date to packaging lots, assigned batches to transfer or
dumping bulks in SAP system.
• Prepared and issued manufacturing record and packaging records.
• Identified records with temporary hold in SAP and in Master Batch Records.
• Stamped effective date to current Master Batch Records.
• Organized and maintained the device master record files.
• Documented supported in APR’s, Change Control, Library, SOP’s and Logbook Center Areas.
• Supported and provided documentation for third party company (Quantic). Assisted CAP trainings.
• Shared electronic documents to SharePoint system.

2. Emely Hernández Hilerio Page 2
Pfizer Consumer Healthcare, Guayama, Puerto Rico
Product Specification Data Analyst 2006 – 2010
• Typed, edited, proofreading and verified Master Packaging and Manufacturing Batch Records (work
instructions, manufacturing process, policies, and procedures).
• Organized and issued Master Packaging and Manufacturing Records and BOM’s.
• Prepared, organized and maintained the device master record files (electronic and hardcopy files).
• Audited History versions of Packaging and Manufacturing Batch Records to be sent to Record Retention
area.
• Supported Packaging Project Management in order to re-design Master Packaging Records.
• Maintained logistic of Electronic Master Batch Records (MES).
• Provided training as required to new employee area and assist with the SOP’s training.
• Maintained an inventory of supplies items used in the Department. Audited 5’s and Safety in the Office
Area.
Education
Interamerican University, Aguadilla, Puerto Rico
BS Psychosocial Human Services
Pontifical Catholic University, Ponce, Puerto Rico
MS Industrial and Organizational Psychology
Psychology License #5465
Trainings
• Investigations and Corrective and Preventive Action (CAPA), J&J Share Services
• Inventory System (SAP R6), J&J Share Services
• Current GMP 21 CFR 210 & 211, J&J Share Services
• Handling Investigations, J&J Share Services
• Train the Trainers
Memberships
• Member of Psychology Association of Puerto Rico