Quality Assurance Engineer
Resume:
Eve M. Carollo ***.*******@*****.***
EXPERIENCE:
Stryker (Contracted through Kelly Science, Engineering, and Technology Services) Weston, FL Quality Engineer, EUMDR (Contractor) September 2021 - April 2023
• CA II Certified, EU MDR_Mahwah DPM / Project Odyssey DPM
• Global Quality & Operations for Standard Operating Procedure (SOP) and Work Instruction
(WI) Revision,
Production Part Approval Process (PPAP), Global Impact Assessment (GIA)-ECR/ECN, and Inspection Guide
Sheet (IGS) to reflect Drawing and Specification
• Expertise in critical and analytical thinking, troubleshooting, and problem solving
• Stakeholder and supplier communication and collaboration in accordance with ISO 13485 guidelines
• Operating Systems: onePLM, Expandable ERP, Stryker Learning Management Systems
(SLMS) ComplianceWire, Microsoft Excel, Outlook, and Teams ADMA Biologics Boca Raton, FL
Quality Assurance Specialist II July 2019 - December 2020
• Biopharmaceutical for Plasma IgG Fractionation and Purification; Inspection, Oversight, Troubleshooting, and Support for QE, QADC, QC, PD, AD, MFG, Metrology, Engineering, and Facilities-Maintenance
• Technical Writing for Investigations, ECR/ECN, Deviations, Master Batch Record (MBR) and SOP Revision
• Quality Management System (QMS) implementation, maintenance, and management support Zimmer Biomet 3i (Contracted through Advanced Clinical) Palm Beach Gardens, FL Cell Support Specialist (Contractor) August 2018 - July 2019
• Medical Device Inspection according to Blueprint Specifications in collaboration with Quality Assurance, Engineering and Machinists with the use of measuring devices, and equipment calibration; Gauges, Calipers, Micrometers, Dial Indicator, Vertex, Vector, Comparator, Transparent Overlay, and LED Light Meters
SHL Pharma Deerfield Beach, FL
Quality Control Technician August 2017 - August 2018
• Medical Device Drug Delivery Systems; Inspection, Testing, Labeling, and Packaging for Validation, Protocols, Engineering Change Orders (ECO), Clinical, Commercial, and Stability Studies
• Incoming Inspection/Pre-Sampling and Design Verification; as per 21 CFR 201 Regulations for Materials; Pharmaceutical Drugs, Excipients, Components, Labels, Finished Devices, and Final Products with Technical Specifications, Certificate of Analysis, and Certificate of Conformance
• Device Inspection and Assembly for Functional Testing and Container Closure Integrity Test
(CCIT) for Dye Ingress Under SHEL LAB Vacuum Oven
• Technical Writing tasks for Out of Specification (OOS) Reports, Investigations, and SOP(s)
• Analytical, and Trend Reporting for testing results and customer complaints/adverse events
• Equipment and Testing Instruments / Operating Systems and Programs; Instron, JOHO, Fully Automatic Testing Machine (FATM), Mins Wizard, Blue Hill, and ST-ITE-v2.0, Johnson Control, CEMS (Vaisala), LabWatch, ComplianceWire, and iLearn Teva Pharmaceutical Industries Davie, FL
Quality Assurance Inspector II August 2011 – August 2017
• Awarded “Above and Beyond” Employee Recognition and Rewards
• Teamwork Excellence in ensuring GMP, FDA and OSHA compliance within the departments of Quality, Manufacturing and Facilities with the methods of Opex, Kaizen and Lean Six Sigma
• “Train the Trainer” Certified and trained 50+ employees on procedures, compliance and safety
• Employee Recognition Rewards: Teva Merger Corporate Audit, and Material Disposition
• Technical Writing Assignments for Investigations, and SOP revisions
• Adverse Event Reports; Customer Complaint Root Cause Analysis, Trending and Outlier Summaries
• Extensive knowledge and experience with Formulation, Wet Granulation, Dry Granulation, Fluid Bed, Oven and Milling processes and equipment; high and low shear mixers, tablet compression, capsule filling, pressurized tanks, high and low shear granulators, blenders, hot melt extruders, compression equipment, encapsulators, tablet pan coaters, pump skids, Glatt extrusion/spheronization, fluidizer drying, granulation, and coating, Comill and Sweco sifter
• Assisted Validation and R&D departments with Protocols, In-Process and equipment validation
• Operating Systems: Microsoft, PowerPoint, TrackWise, Soft Expert, SAP, and JDE Bank of America - Home Loans New York, NY
Mortgage Underwriter September 2005 - August 2008
Nature’s Bounty Bohemia, NY
Quality Assurance / Documentation Specialist January 2001 - July 2005 Luitpold Pharmaceuticals Shirley, NY
Quality Assurance Inspector June 1993 – May 1999
• Sterile (aseptic environment) for manufacturing of injectable pharmaceuticals EDUCATION and CERTIFICATIONS:
Sanford-Brown College Fort Lauderdale, FL
Associate in Science in Allied Health 3.88 GPA Honors Graduate Pharmacy Technician Diploma
- State of Florida Department of Health (DOH): Registered Pharmacy Technician
- Pharmacy Technician Certification Board (PTCB): Certified Pharmacy Technician (CPhT)
- National Institutes of Health (NIH): Protecting Human Research Participants Certification
- National Safety Council: First Aid Course Certification November 2010
- American Heart Association: CPR & AED November 2010 LifeExtension Rx & Clinical Research Fort Lauderdale, FL Clinical Trials / Pharmacy Technician (160 Hrs Externship)
• Pharmacy Techniques and Operations, Prescription Interpreting, Labeling and Processing
• Medication and Supply Management; Storage, Inventory, Ordering, Invoicing, and Filing
• Customer Service, Medical Insurance Claim Form, Record Preparation and Processing
• Human Clinical Trials Study; Subject Recruiting, Screening and Examinations
• Study product and screening packet Preparation, Distribution and Documentation
• Laboratory specimen Retrieval, Observation and Daily Log, Data Entry, QS1-Nix William Floyd High School Mastic Beach, NY
High School Diploma
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