Melissa López Hernández
General Physician
Isabela
Summary
Highly motivated and compassionate Medical Doctor with a strong foundation in patient care, eager to leverage comprehensive knowledge in clinical medicine. Seeking to secure a position in a dynamic healthcare setting where I can contribute to high-quality patient care while continuously advancing my medical expertise.
Overview
3
3
Certification
Work History
Medical Intern
Hospital de La Concepcion
San German
05.2022 - 07.2024
- Rotated through all the major and minor specialties, including Internal medicine, Surgery, Pediatrics, Emergency medicine, and Obstetrics & Gynecology
- Participated in daily rounds, providing comprehensive patient evaluations and assisting attending physicians in the diagnosis and development of treatment plans
- Collaborated with healthcare professionals across specialties, including cardiologists, neurologists, nephrologists, infectologists, and surgeons to ensure holistic patient care
- Gathered patients' history, conducted physical examinations, formed impression for diagnosis, offered recommendations for follow up and treatment
- Analyzed test results and information gathered during examinations to properly diagnose illnesses and diseases
- Assisted in data entry and maintenance of highly-sensitive patient information into EMR
- Carried out medical and surgical procedures under attending physician supervision
- Monitored patients' progress in response to medical management
- Counseled patients on medical conditions and management
- Engaged in active learning opportunities, including participation in grand rounds and case conferences to enhance clinical knowledge and patient care strategies
Analyst Commodity III
AbbVie
Barceloneta
05.2020 - 05.2022
- Provided daily production/operational SAP support to Manufacturing, Quality, Supply Chain, and Warehouse areas to ensure business operations are not interrupted
- Performed SAP and/or LIMS recipe redlines for new or existing materials
- Analyzed and developed solutions to meet business needs across the SAP system
- Participated as an active team member in the implementation of SAP S/4 HANA system upgrade
- Responsible for supporting and independently completing project tasks
- Conducted SAP S/4 HANA new transaction codes evaluation with respect to usability, testability, supportability, and performance according to each applicable area
- Worked closely with SAP Functional Teams to coordinate and ensure complete enhancements to company’s SAP implementation
- Responsible for editing and updating Standard Operating Procedures (SOPs) with the new SAP S/4 HANA transaction codes
- Responsible of developing, coordinating, and providing SAP S/4 HANA new transaction codes training to each applicable area
- Completed impact assessment and performed SOP changes in a timely manner prior to the SAP S/4 HANA system implementation
- Ensured a seamless, continuous transition of the new SAP system platform and the resolution of events were completed in a timely manner
Labeling Specialist
Integra LifeSciences
Añasco
03.2020 - 04.2020
- Professional Services via MedChem Engineering
- Reviewed and developed labeling materials to ensure that is in compliance with applicable regulations such as: label standards, barcode standards, and Global Unique Device Identification Database (GUDID) attributes
- Created redlines to modify existing artworks and procedures per regulatory and customer requirements
- Executed the label and Instructions For Use (IFU) functions including the creation, editing, and processing of labeling changes
- Executed audits to text, format, illustration, and multi-lingual databases as required
- Generated Engineering Change Orders (ECO’s) to create new or modify catalogs, Bill of Materials (BOM) and artworks
- Ensured labels and artworks were completed on-time to comply with customers’ needs
Quality Assurance Specialist
AbbVie
Barceloneta
03.2018 - 12.2019
- Executed audits of process Electronic Batch Records (EBR) and Process Control Records (PCRs) and measured quality data for review to ensure finished products complied with quality standards prior to release
- Audited, approved, and dispositioned raw materials, intermediates, and finished products utilizing POMSnet MES and SAP systems
- Conducted detailed frontline audits providing Quality oversight to ensure that products were manufactured according to current Good Manufacturing Practices (cGMP) and the compliance of manufacturing areas with the Standard Operating Procedures (SOPs) and Quality System
- Interacted and worked in conjunction with Quality and Manufacturing management in order to identify strategies and objectives for product quality and Good Manufacturing Practices (GMP) compliance
- Prepared Certificate of Compliance (CoC) and Certificate of Analysis (CoA) for clinical and commercial products according to product specifications and regions
- Engaged and collaborated with cross-functional teams such as manufacturing, technical operations, and regulatory in completing production activities
- Performed Right First Time (RFT) trending data reports and reported to management on a monthly basis
- Reviewed and approved MES exceptions and operational notes assuring that the root cause evaluation and material disposition were performed in compliance with the Standard Operating Procedures and Quality System
- Evaluated and ensured that all process deviations and/or investigations were identified, reported, and properly documented according to procedures and Quality System
- Ensured that all CAPAs and other required documentation related to the batch records were completed and closed prior to material/lot release
- Rendered support to the Manufacturing engineering and Manufacturing Execution System department in the development, validation, and implementation of new Electronic Batch Record recipes
- Participated in process improvements such as Release by Exception to achieve simplification of the audit process and reduce batch record review touch time and backlog
- Determined trends and areas for improvement as well as delivered valuable input to Quality management to enhance training or create action plans to address issues
Medical Office Assistant
Dr. José A. López Pérez
Isabela
10.2017 - 12.2017
- Assisted physician in exam rooms, measured vital signs, including weight, blood pressure, pulse, temperature, and documented all information in patient’s medical record
- Checked-in patients and collected personal, medical, and insurance information
- Answered incoming phone calls and scheduled patient appointments
- Entered correct and/or updated patient information into electronic medical record (EMR)
- Reinforced patient confidentiality as required by HIPAA guidelines
- Filed and retrieved medical records
Quality Analyst
AbbVie
Barceloneta
06.2016 - 10.2016
- Analyzed, reviewed, and approved MES generated exceptions and discrepancy forms while guaranteeing that the root cause investigation and material disposition was performed in compliance with the Quality System
- Initiated adequate system of internal control by enforcing the compliance of Good Manufacturing Practices and Quality corporate policies
- Ensured that process deviations were properly reported and documented in compliance with the established procedures and Quality System
- Resolved Non-Conformance issues by creating and formulating remedial action plans while implementing corrective and preventive actions
- Performed root cause analysis with direct correlation to audit findings with a focus to improve the overall process
- Reduced MES exceptions backlog and achieved timely approval to comply with batch record release timelines
- Performed Quality track and trend metrics and reported to management on a quarterly basis
- Introduced, recommended, and executed preventive/corrective actions to minimize discrepancies
Quality Assurance Specialist
AbbVie
Barceloneta
06.2015 - 05.2016
- Executed audits of process Electronic Batch Records (EBR) and Process Control Records (PCRs) and measured quality data for review to ensure finished products complied with quality standards prior to release
- Audited, approved, and dispositioned raw materials, intermediates, and finished products utilizing POMSnet MES and SAP systems
- Interacted and worked in conjunction with Quality and Manufacturing management in order to identify strategies and objectives for product quality and Good Manufacturing Practices (GMP) compliance
- Prepared Certificate of Compliance (CoC) and Certificate of Analysis (CoA) for clinical and commercial products according to product specifications and regions
- Evaluated and ensured that all process deviations and/or investigations were identified, reported, and properly documented according to procedures and Quality System
- Ensured that all CAPAs and other required documentation related to the batch records were completed and closed prior to material/lot release
- Rendered support to the Manufacturing Execution System department in the development, validation, and implementation of a new quality audit tool as part of the Release by Exception project
GMP Production Specialist
AbbVie
Barceloneta
06.2014 - 06.2015
- Audited intermediate materials and finished product Electronic Batch Records using POMSnet MES, and Process Control Records (PCRs) prior to submitting to Quality Assurance
- Engaged and interacted with other departments to analyze and resolve process related discrepancies
- Assured conformance of activities to Manufacturing Standard Operating Procedures and Good Manufacturing Practices (GMP)
- Reviewed and evaluated all deviations documented in the batch records and assured that they were properly completed and approved
- Proposed and implemented corrective actions with Quality, Manufacturing, and Technical operations to minimize non-conformance recurrences
- Performed improvements and changes to Standard Operating Procedures
- Created and consolidated reports by using Microsoft Word and Excel to provide analyses and recommendations on auditing activities and error trends
Quality Assurance Batch Record Auditor
LifeScan
Aguadilla
06.2012 - 08.2013
- Contractor via Kelly Services
- Performed on-the-floor review and approval of process batch records assuring conformance of activities to Quality Assurance and Manufacturing Standard Operating Procedures
- Performed on-the-floor line clearances of production lines and reported any deviations
- Oversaw remediation activities required to continue production
- Completed Non-Conformances actions to release product assuring that investigations were completed and properly approved
- Assured proper identification of release status and control of materials used during the manufacturing process
- Utilized analytical acumen to inspect and approve incoming materials by confirming specifications, conducting visual and measurement tests, and rejecting non-conforming materials
- Rendered support to Manufacturing engineers and Quality engineers in the development and implementation of Manufacturing Execution Systems (MES) for Electronic Batch Records
- Assisted in training new personnel on batch record auditing process by providing On the Job Training (OJT)
Quality Assurance Team Leader
Cordis LLC
San German
04.2005 - 08.2007
- Supported QA supervisor to coordinate activities of batch record auditors
- Held the accountability for monitoring quality assessment systems of the organization
- Organized and headed quality and operational audits to support business requirements, and compliance according to documented processes and procedures in line with GMP’s and FDA regulations
- Performed Non-Conformance investigations using effective root cause analysis methodology and implemented preventive/corrective actions
- Worked closely with members of Production and Quality teams during investigations to determine root cause and potential preventive/corrective actions and ensured timely closure of investigations
- Supervised 15 batch record auditors, as well as, reduce batch record audit and release cycle time by 50%
- Enhanced productivity and maintained the quality of the products by performing improvements and changes to Standard Operating Procedures
- Arranged and led development sessions for new personnel and ensured compliance with departmental procedures
- Was assigned the QA Team Leader role in the development and implementation of Manufacturing Execution Systems (MES) for Electronic Batch Records
Quality Assurance Batch Record Auditor
Cordis LLC
San German
06.2003 - 04.2005
- Reviewed, approved, and dispositioned Master Batch Records assuring conformance of manufacturing activities to quality standards, and standard operating procedures
- Reviewed all documentation for GMP compliance
- Assured proper identification of release status and control of materials used during the manufacturing process
- Reviewed, approved and dispositioned raw materials, in-process materials, and finished products
- Supported and collaborated with other departments to develop and implement Corrective and Preventive Actions (CAPA) reducing non-conformance recurrences
Education
Doctor of Medicine, M.D. -
Universidad Iberoamericana School of Medicine (UNIBE)
Santo Domingo, Dominican Republic06.2012
Bachelor of Science -
Radford University
Radford, Virginia05.2001
Skills
- Patient care
- Diagnostics
- Electronic Medical Records (EMR)
- HIPAA Privacy Rule
- Verbal and written communication
- Time management
- Multitasking abilities
- Collaboration and Teamwork
- Problem solving
- Critical thinking
- Bilingual (Spanish and English)
- Microsoft Office Word, Excel, Power Point, Outlook
Certification
- Puerto Rico Medical License
- CPR/Basic Life Support (BLS), American Heart Association
- Advanced Cardiovascular Life Support (ACLS), American Heart Association
- Pediatric Advanced Life Support (PALS), American Heart Association
Timeline
Medical Intern
Hospital de La Concepcion
05.2022 - 07.2024
Analyst Commodity III
AbbVie
05.2020 - 05.2022
Labeling Specialist
Integra LifeSciences
03.2020 - 04.2020
Quality Assurance Specialist
AbbVie
03.2018 - 12.2019
Medical Office Assistant
Dr. José A. López Pérez
10.2017 - 12.2017
Quality Analyst
AbbVie
06.2016 - 10.2016
Quality Assurance Specialist
AbbVie
06.2015 - 05.2016
GMP Production Specialist
AbbVie
06.2014 - 06.2015
Quality Assurance Batch Record Auditor
LifeScan
06.2012 - 08.2013
Quality Assurance Team Leader
Cordis LLC
04.2005 - 08.2007
Quality Assurance Batch Record Auditor
Cordis LLC
06.2003 - 04.2005
- Puerto Rico Medical License
- CPR/Basic Life Support (BLS), American Heart Association
- Advanced Cardiovascular Life Support (ACLS), American Heart Association
- Pediatric Advanced Life Support (PALS), American Heart Association
Doctor of Medicine, M.D. -
Universidad Iberoamericana School of Medicine (UNIBE)
Bachelor of Science -
Radford University
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