Erika Saldaña
Haines City
Summary
Seeking to transition into a new field, leveraging transferable skills to contribute to a different industry. A quality professional with a solid background in process improvement, quality assurance, and regulatory compliance. Adept at fostering team collaboration, adapting to changing needs, and delivering measurable outcomes. Known for effective problem-solving, keen analytical skills, and a commitment to maintaining high standards. Dependable and versatile, ensuring quality and efficiency in all tasks.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Food Safety and Quality Expert
Givaudan Flavor
01.2014 - Current
- Contributed to the development and revision of the local Quality and Food Safety program
- Supervised the effectiveness of the sanitation process, assuring plant compliance with food safety (HACCP) programs
- Developed and provided training for food safety and quality requirements for all active employees
- Led the local Food Safety and Defense Team, and provided all training as needed
- Led the Regional Environmental Monitoring Program Team
- Performed and managed Food Safety Inspections
- Provided risk assessment, improvement plan, and monitoring of the Food Safety Program
- Provided support to vendor audits, local vendor & customer quality programs
- Provided support to several regional Food Safety and Quality Management projects
Laboratory Technician-Chemical
Aplicare
01.2010 - 01.2014
- Conducted quality control testing of process bulk solutions, finished products, raw materials, and stability per Aplicare Specifications
- Performed daily verification checks & calibration on lab equipment to ensure proper operation
- Monitored product quality to ensure compliance with standards and specifications
- Compiled and interpreted results of tests and analyses
Regulatory Conformance Analyst
GlaxoSmithKline
01.2005 - 01.2008
- Verified that the creation or modifications of the Master Production Records were by applicable product licenses, registrations, CPS, and Technical Terms of Supply
- Contributed to the development, revision, and approvals of the Master Production Records ensuring compliance with cGMPs, corporate guidelines, and applicable regulations and laws
- Reviewed and performed, the significance determination of the Change Control Proposal
Education
Master Degree - Business Administration Mayor in Management
Metropolitana University of Puerto Rico
Cupey, Puerto RicoBachelor Degree - Biology Majored in Biomedicine and Microbiology (Magna Cum Laude)
Interamericana University of Puerto Rico
Fajardo, Puerto RicoSkills
- Preventive actions
- Laboratory safety protocols
- Microsoft office
- Customer satisfaction
- MS Excel
- Team collaboration and leadership
- Risk analysis
- Project management
Accomplishments
- Developed and implemented a technical solution for Environmental Monitoring Program data facilitating the data revision and reducing the cycle time by approximately 50%.
- Provided a systematic approach to the early identification and management of risks by adopting risk treatment strategies that are cost-effective and efficient in reducing risk.
- Actively participated in and implemented the Remediation of Packaging Batch Records and obtained zero observations in internal and FDA audits.
- Received an award from GSK for contributing to the category of Passion and urgency.
Certification
- Six Sigma Certification
- PCQI and HACCP Certification
- Food Defense Coordinator
- ISO 9001-2015 and FSSC 22000
- ISO 17025 Internal Auditing Training
Timeline
Food Safety and Quality Expert
Givaudan Flavor
01.2014 - Current
Laboratory Technician-Chemical
Aplicare
01.2010 - 01.2014
Regulatory Conformance Analyst
GlaxoSmithKline
01.2005 - 01.2008
Bachelor Degree - Biology Majored in Biomedicine and Microbiology (Magna Cum Laude)
Interamericana University of Puerto Rico
Master Degree - Business Administration Mayor in Management
Metropolitana University of Puerto Rico
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