ELSA M. ARIZABAL
Fresenius Medical Care
American Canyon,CA
1
Certification
22
years of professional experience
Quality control professional with extensive experience in pharmaceutical and medical device manufacturing, supporting GMP compliance, inspections, and documentation review. Routinely release or reject materials based on acceptance criteria, review device history records, and verify calibration and packing documentation to support accurate, compliant production.
Work History
Senior Quality Control Inspector
7 Years 3 Months- Released or rejected inspected materials and products based on acceptance criteria.
- Drafted and enforced quality control operating procedures, ensuring alignment with internal and regulatory compliance standards.
- Reviewed and approved device history records for accuracy, completeness, and compliance with company procedures.
- Monitored quality checks across multiple job sites, coordinating updates and documentation to ensure consistent compliance.
- Reported product defects, safety hazards, and process deviations to the quality engineer and the production supervisor to support issue correction.
- Verified and signed certificates of conformance and packing lists, confirming accurate part quantities and compliance with order specifications.
- Maintained updated QC inventory of all materials to prevent downtime during production and QC inspection.
- Verified calibration dates and functionality of inspection equipment, machinery, and tools for quality control use.
- Executed equipment cleaning and setup procedures for production batches to ensure operational efficiency.
- Interpreted engineering drawings for packaging materials to confirm package fit, protection, and dispensing function.
Documentation Specialist
2 Years 7 Months- Reviewed and approved the device history record to check and sign off on all production and testing records before shipping.
- Organized and maintained all manufacturing and quality records to ensure accessibility and compliance.
- Executed filing, copying, scanning, collating, data entry, and document archiving to streamline record management processes.
- Performed routine inspection of devices for cosmetic, configuration and labeling acceptability according to BOMs, engineering drawings and data sheets.
- Initiated nonconformance to ensure that the data of observation is accurate and truly deviates from the established specifications or standard.
- Communicated unresolved issues to the supervisor to facilitate timely resolution and maintain operational efficiency.
Quality Control Technician IV/III/II/I
10 Years 5 Months- Conducted final QA/QC inspection to approve and release the drug product at the filling and packaging process.
- Reviewed inspection and documentation to determine final disposition, ensuring compliance with quality standards.
- Isolated defective products and materials during packaging operations, placing them on QA hold to prevent distribution of non-conforming items.
- Initiated rework instructions in a production line when defects were found during QC process inspections.
- Performed line clearance checklist in filling and packaging area to ensure all materials, products, and documentation from the previous run were completely removed before starting a new lot.
- Oversaw reconciliation of unused packaging materials post-operation to ensure accountability and prevent product mix-ups.
- Extremely detailed and accurate in maintaining comprehensive laboratory logbooks and all raw materials databases.
Education
High School Diploma
Certified Pharmacy Technician
Skills
Quality Control Planning
Quality assurance
Good Manufacturing Practices
GMP compliance
Quality assurance planning
Standard Operating Procedures
Good Documentation Practices
Production Device History Record Review
Production Batch Record Review
Document management
Quality assessment
Quality processes
Product Shelf Life Monitoring
Defect Tracking
Defect identification
Rework
Deviations
Inspections and reviews
Quality Product Testing
Calibration checks
Equipment calibration
Manufacturing processes
Production skills
Process improvement
Analytical Data
Sampling methods
Sampling techniques
Material testing
Material analysis
Raw materials testing
Visual assessment
Color matching
Dimensional inspection
Inspection methods
Surface inspection
Packaging inspection
Line clearance
Area Approval Line Clearance
Ingredient dispensing
Calibration techniques
Test equipment operation
Audit coordination
Quality Data Management
Data reporting
Performance monitoring
QIIS (Quality Inspection Information System)
Business planning system
Manufacturing execution system
SAP (Software Application Program)
Quality assurance
5s / Lean
Six sigma principles
OSHA compliance
Inspection records
Compliance monitoring
ISO standards
Attention to detail
Analytical thinking
Problem Solving
Cross-Functional Collaboration
Training and mentorship
Staff oversight
Training mentorship
Issue escalation
Division monitoring
Process evaluation
Error reduction
Drawing interpretation
Blueprint reading
Blueprint interpretation
Schematics
Geometric dimensioning
Forms management
Quantity verification
Recordkeeping
Nondestructive testing
Safety procedures
Safety protocols
Compliant Enforcement
QC planning
Recordkeeping
Raw materials testing
Sampling techniques
Compliance monitoring
ISO standards
Quality assurance
Forms management
Equipment calibration
Nondestructive testing
Audit coordination
Inspection records
Safety protocols
Specifications reading
Test equipment operation
Quantity verification
Production Equipment Management
Data analysis
Performance monitoring
Quality Received
Quality Excellence Award, Quality Assurance Award “Excellence in teamwork”, Recognized for Outstanding service and contribution to Quality Control Department
Certification
- Certified IPC Specialist (IPC-A-610 - Acceptability of Electronic Assemblies)
Timeline
Senior Quality Control Inspector
Fresenius Medical Care
05.2017 - 08.2024Read More
Documentation Specialist
Fresenius Medical Care
09.2014 - 04.2017Read More
Quality Control Technician IV/III/II/I
Mylan Specialty L.P. Pharma
02.2003 - 07.2013Read More
Santa Cruz Academy
High School Diploma
Read More
Boston Reed College
Certified Pharmacy Technician
Read More