Kayla Diane Caron
North Smithfield
Summary
Detail-oriented professional with 16 years of experience in biotechnology-related industries. Proven track record in driving impactful results through strategic planning and effective execution. Strong focus on team collaboration and adaptability to dynamic environments. Skilled in project management, problem-solving, and effective communication. Experience includes expertise in GMP/GxP, GDP, packaging and labeling operations, warehouse operations, quality assurance operations, FDA, DEA, regulatory experience, process improvement initiatives, and proficiency in software tools such as Word, Excel, PowerPoint, SAP, Geode+, Phenix, IObeya, Veeva Vault, Trackwise, and Veeva (VeeDMS & VeeQMS).
Overview
11
11
years of professional experience
1
1
Certification
Work History
Operational Area Quality Systems Senior Specialist, and Senior Training Coordinator
Vertex Pharmaceuticals
08.2022 - 08.2025
- Lead in quality support for document control including Issuance and archiving
- Coordinates with cross-functional teams to develop, implement, and improve processes.
- Steer collaboration with the global quality systems team to ensure sites stay in compliance with the global requirements.
- Coordinates training activities for various departments within a GxP environment as a Training Coordinator
- Leader in developing processes to support the organization’s records management system, including assisting in the transition from paper-based to an electronic document and records management system.
- Responsible for coordinating the training staff in use of the electronic document management system.
- Aids quality record owners with ensuring compliance with SOP requirements.
- Responsible for identifying risks and communicating any gaps for quality processes optimization.
- Participates in inspection readiness and support activities.
Quality Assurance Compliance Specialist Senior (Lead)
Sanofi Genzyme
06.2016 - 07.2022
- Execute the responsibilities relating to the quarantining, sampling, testing, inspection and disposition/release of all Raw Materials, Chemicals, Final Packaging Materials
- Drug product release
- On time proficiency in completing On the Job Trainings and the training curriculum
- Certified Job Trainer
- Strictly adhere to all cGMP guidelines and operations
- Support QA department initiatives for improvement of quality of the QCRM/ Finished Product departments.
- Super User Athena/SAP -trainer
- Super user for Geode+ programming- trainer
- Involvement with Reject/Q-hold functionality
- Bill of Material Approval and Part number activation knowledge
- Knowledge and expertise in Manufacturing process
- Leader in QA initiatives to improve processes and understanding in Value added Vs. Nonvalue added workload.
- Knowledge and Understanding in Finished Product Release
- Team Leader and mentor for training and advising.
- Expert Specification and Standard Procedure Revisions
- Familiarity with Deviations, Change Controls in Phenix
Clinical Supply Label and Packaging Technician
Sanofi Genzyme
11.2014 - 09.2015
- Prepare, read, and understand GMP documentation for Operations.
- Prepare documentation, set up materials and complete execution of Packaging and Labeling operations.
- Complete documentation and Clinical Inventory Management System (CIMS) transactions for in-house & vendor printing operations
- Review and adhere to Standard Operating Procedures for accuracy and improvement.
- Prepare batch record documentation for various clinical studies.
- Execute activities in the CIMS for packaging and labeling job fulfillments.
- Perform cycle counts and inventory checks for components, drug, and all labeling materials.
- Perform second operator duties in verification.
- Accurate document on Batch Record Official documents
- Understand and Participate in all cGMP policies and procedures.
Education
Bachelor of Science - Biotechnology
Rhode Island College
Providence, RI05-2027
Associate in General Studies - General Studies
Community College of Rhode Island
Lincoln, RI05.2012
High School Diploma -
North Smithfield High School
North Smithfield, RI05.2007
Skills
- Innovation process optimization
- Data-driven decision making
- File management expertise
- Team collaboration
- Coaching and mentoring
- Continuous improvement
- Problem-solving
- Verbal and written communication
Accomplishments
- Dean’s list
- State- 3rd Division All Star Volleyball Player
- National Pharmacy Technician Boards with score of 818/900
- RAPTAR Customer Service/ Employee Recognition and Appreciation Award
- Qualified Trainer
- Expert/Leader in GEODE+ programming- Leader for change
- LEAN Introductions- SMS Practitioner Certification
Certification
· Dean’s list
· State- 3rd Division All Star Volleyball Player
· National Pharmacy Technician Boards with score of 818/900
· RAPTAR Customer Service/ Employee Recognition and Appreciation Award
· Qualified Trainer
· Expert/Leader in GEODE+ programming- Leader for change
· LEAN Introductions- SMS Practitioner Certification
· LEAN Bootcamp Certified
· OILS (Observe Inquire Listen) Feedback Training Completion
· LEADER for Fit4Change
· LEAN Practitioner Level- Sanofi Manufacturing System
· SMS (Sanofi Manufacturing System) Champion May 2022
· White Belt: Vertex Pharmaceuticals Six Sigma Certification
· ASQ-CQIA Certified Quality Improvement Associate 2025
Timeline
Operational Area Quality Systems Senior Specialist, and Senior Training Coordinator
Vertex Pharmaceuticals
08.2022 - 08.2025
Quality Assurance Compliance Specialist Senior (Lead)
Sanofi Genzyme
06.2016 - 07.2022
Clinical Supply Label and Packaging Technician
Sanofi Genzyme
11.2014 - 09.2015
Bachelor of Science - Biotechnology
Rhode Island College
Associate in General Studies - General Studies
Community College of Rhode Island
High School Diploma -
North Smithfield High School
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