Dagmar Enid Córdova Manzano
Caguas
Summary
- Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
1
1
Certification
Work History
QA Specialty-Product Desposition
Merck
Las Piedras, Puerto Rico
2015 - 2024
- Assisted in developing training materials related to quality assurance topics.
- Coordinated activities with other departments related to product release decisions.
- Maintained knowledge of current industry developments and regulatory requirements for quality assurance purposes.
- Review Batch Records documentation concerning to raw materials, packaging components, product intermediates, bulk product and finished packaged products according to current standards operating procedures.
- Provides timely feedback to management regarding situations that may result in product impact and/or release delays.
- Support site projects, new products and other process improvements.
- Support sites audits, regulatory and corporate inspections including support to audit responses.
- Review and approve minor deviations assuring accuracy, completeness and documented evidence including cross functional evaluation, risk assessments, remedial, corrective and preventive actions.
- Conducts trend analysis (per cause and products), identifies and recommends action to ensure a state of continued compliance avoiding recurrence.
- Generate APR's sub-reports related to QA area. Support on any other supervisory request according to experience and qualifications.
Change Management Specialist
Merck
Las Piedras, Puerto Rico
2007 - 2015
- Generate change request and evaluating changes to documents, equipment, facilities, procedures, areas and computerized systems to ensure are complete by their due dates.
- Tracked project schedules and encouraged teams to complete tasks on time.
- Organized client meetings to provide project updates.
- Oversaw quality control to identify inconsistencies and malfunctions.
Microbiologist
Merck
Las Piedras, Puerto Rico
2002 - 2007
- Testing raw material and finish product, including solutions.
- Sampling manufacturing and laboratory areas (environmental and surfaces monitoring), including the water systems.
- Creation of microbiology protocols and laboratory data verification.
- Interpreted test results accurately ensuring that all data is reported properly.
- Provided technical support for troubleshooting issues related to equipment or processes in the laboratory environment.
- Monitored microbiological tests including sterility testing, total plate count, bioburden testing and endotoxin testing.
- Ensured compliance with applicable regulations governing laboratory operations.
- Trained personnel on laboratory functions.
- Designed individual testing calibrators.
Education
Bachelor of Science - Microbiology
Universidad Interamericana
Recinto Metropolitano12-1990
Skills
- Regulatory and GMP Compliance
- Concise Communication
- Punctual
- Ethical
- Industry Knowledge of SAP ( System, Applications, and Product in data processing) Trackwise, MEDS, GLIMS, MIDAS, IPI, QualityDoc, and eShopfloor
- Organized
- Dynamic
- Quality Oriented
- Helpful
- Passionate
- Industrial brigade team member
- EBRG ( employee business resource group) of Rainbow Alliance
Languages
- Spanish (Native)
- English
Certification
- Heartsaver First Aid RCP and DEA - DEC/2023
References
References available upon request.
Timeline
QA Specialty-Product Desposition
Merck
2015 - 2024
Change Management Specialist
Merck
2007 - 2015
Microbiologist
Merck
2002 - 2007
Bachelor of Science - Microbiology
Universidad Interamericana
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