Summary
Overview
Work History
Education
Skills
Languages
Websites
References
Timeline
Generic

Fabiola Kuppens

Elk Grove,USA

Summary

Safety-centric Quality Specialist with over a decade of combined experience excelling within diverse manufacturing, research, and laboratory environments – applying strong technical, analytical and problem-solving skills.

Overview

15
15
years of professional experience

Work History

Manufacturing Quality Assurance Auditor

MEDIATECH
Woodland, CA
06.2024 - 12.2024
  • Company Overview: Corning subsidiary
  • Played instrumental role in batch records management including generation and completing comprehensive reviews to maintain top levels of accuracy and organization.
  • Reviewed and processed extensive amounts of data as well as provided document control – covering creation, revision, and routing functions as well as overall workflow.
  • Implemented corrective actions to resolve and prevent process gaps.
  • Inspected raw materials according to quality standards and approved materials for use in production.
  • Corning subsidiary

Quality Systems Specialist

MILLIPORE SIGMA
Rocklin, CA
11.2023 - 04.2024
  • Document Review ensuring compliance with operational policies, procedures, regulations, and quality standards.

Quality Assurance Associate

LGC BIOSEARCH TECHNOLOGIES
Novato, CA
07.2022 - 09.2023
  • Performed a wide range of QA operations, ensuring compliance with operational policies, procedures, regulations, and quality standards.
  • Played instrumental role in batch records management, completing comprehensive reviews to maintain top levels of accuracy and organization.
  • Reviewed and processed extensive amounts of data as well as provided document control – covering creation, revision, and routing functions as well as overall workflow.
  • Identified, researched, and reported non-compliance issues, recommending additional training of team members and organizing interventions to eliminate gaps and boost performance.
  • Facilitated diagnosis and resolution of quality issues by establishing and promoting culture of analytical thinking, precision, and diagnostics as well as cross-functional cohesion through enhanced communications.

GMP Associate-GMP Tech I-Inventory Coordinator

LGC BIOSEARCH
Novato, CA
01.2020 - 07.2022
  • Excelled in collaborative team and independent work atmosphere, effectively processing Oligonucleotides Formulation in alignment with strict protocols – expertly reviewing and following complex and highly detailed manufacturing instructions.
  • Implemented laboratory safety procedures, achieving goals without compliance issues.
  • Elevated product reliability through strategic planning of corrective and preventative actions.
  • Handled documentation changes, deviation reports, inventory counts, and supply audits – including implementation of inventory program to fulfill customer demands.
  • Ensured compliance with policies, procedures, and safety / environmental regulations – monitoring manufacturing performance and recommending improvements as needed.
  • Fueled production while eliminating waste and raising quality through strategic restructuring of operational platform – covering storage and stock planning to enhance freezer configuration.

Science Research Associate II

UNIVERSITY OF CALIFORNIA SAN FRANCISCO
San Francisco, CA
02.2010 - 01.2013
  • Company Overview: Clinical & Translational Science Institute
  • Assigned to various projects concurrently to ensure timely and quality deliverables in alignment with specifications, standards, and safety / infection control regulations.
  • Performed data collection, research, and reporting – encompassing maintenance of laboratory record system.
  • Served key role in efficient and fully-compliant research trials, working collaboratively with investigators and sponsors throughout full lifecycle of projects.
  • Properly handled, processed, labeled, and delivered specimens from trial participants as well as prepared slides for microscopic examination and analysis.
  • Commended for continuously meeting or exceeding workflow needs.
  • Completed training in medical and laboratory procedures as well as principles of medicine.
  • Clinical & Translational Science Institute

Education

Associate of Applied Science - Business Administration

Heald College
San Francisco, CA

Skills

  • Data entry
  • Database administration
  • Inventory control
  • Equipment maintenance
  • Calibration
  • Product disposition
  • 21 CFR 820
  • ISO 9001
  • ISO 13485
  • Commitment to safety standards
  • Process improvement
  • Safe equipment utilization
  • Waste reduction
  • Inventory management
  • Standard operating procedures implementation
  • GMP regulations
  • Audits
  • Non-compliance reporting
  • Documentation review
  • Professionalism
  • Multitasking capacity
  • Computer proficiency
  • Inspect raw materials
  • Batch records management
  • Documentation and recordkeeping
  • Document control
  • Regulatory compliance
  • Corrective actions
  • Effective communication
  • Problem solving
  • Attention to detail
  • Analytical thinking
  • Team collaboration
  • Raw materials review
  • Reporting and documentation
  • Testing data documentation
  • Adaptability
  • Collect samples

Languages

English
Professional
Spanish
Professional

References

References available upon request.

Timeline

Manufacturing Quality Assurance Auditor

MEDIATECH
06.2024 - 12.2024

Quality Systems Specialist

MILLIPORE SIGMA
11.2023 - 04.2024

Quality Assurance Associate

LGC BIOSEARCH TECHNOLOGIES
07.2022 - 09.2023

GMP Associate-GMP Tech I-Inventory Coordinator

LGC BIOSEARCH
01.2020 - 07.2022

Science Research Associate II

UNIVERSITY OF CALIFORNIA SAN FRANCISCO
02.2010 - 01.2013

Associate of Applied Science - Business Administration

Heald College

Similar Profiles

CREATE PROFILE