Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Timeline
Generic

Kimberly Postakis Lambertinis

Rancho Cucamonga,US

Summary

New Graduate Registered Nurse with a Bachelor of Science in Nursing (BSN), and over 10 years of prior experience in regulatory compliance and quality assurance within FDA-regulated, GMP/GDP environments. Brings a strong foundation in patient safety, risk mitigation, and adherence to clinical standards. Recognized for providing accurate assessments, remaining calm under pressure, and collaborating effectively with physicians and interdisciplinary teams to deliver safe, high-quality patient care. Highly organized, detail-oriented, and committed to evidence-based nursing practice.

Overview

10
10
years of professional experience
1
1
Certification

Work History

Quality Assurance Specialist

KC Pharmaceuticals
Pomona
12.2023 - 05.2025
  • Implemented and maintained QA protocols ensuring FDA, GMP, and GDP compliance in manufacturing operations.
  • Led investigations of customer complaints, analyzing laboratory data to identify root causes and implement corrective actions.
  • Collaborated with cross-functional teams to enhance product quality and reduce defect rates.
  • Prepared for FDA audits, ensuring accurate documentation and inspection readiness.
  • Streamlined quality processes, reducing turnaround times and improving customer satisfaction.
  • Discussed effective solutions for major quality issues with management.
  • Assisted in developing and validating testing methods for quality control purposes.
  • Communicated results of quality inspections through detailed reports to management.

Regulatory Compliance/Quality Assurance Analyst

Orchid
Arcadia, CA
09.2022 - 12.2023
  • Conducted internal compliance audits and identified gaps requiring corrective and preventive actions (CAPA).
  • Developed and implemented CAPA plans to resolve non-conformances and enhance regulatory adherence.
  • Calibrated and maintained measurement and testing equipment, ensuring accuracy and data integrity.
  • Delivered quality and compliance training to staff, improving adherence to regulatory standards.
  • Maintained up-to-date regulatory knowledge, responding effectively to internal compliance inquiries.

Manufacturing Technician II

Gilead
San Dimas, CA
10.2019 - 09.2022
  • Supported GMP-regulated manufacturing of nanoparticle products in a controlled environment.
  • Performed equipment calibration, troubleshooting, and maintenance to enhance production efficiency.
  • Reviewed SOPs to ensure quality consistency and regulatory compliance.
  • Produced materials according to precise specifications, ensuring accuracy and reproducibility.
  • Documented manufacturing activities, adhering to GMP and GDP requirements.
  • Operated vial capper, unloading products from lyophilizes and packing vials from liquid fill line.
  • Maintained clean equipment and workplace per mandated clean room protocols.
  • Monitored non-sterile risks to preserve sterile environments.

Quality Assurance Technician

Nellson Nutraceutical
Ontario, CA
12.2017 - 07.2019
  • Conducted quality inspections on in-process and finished products to ensure specification compliance.
  • Performed chemical testing on raw materials, in-process goods, and stability samples.
  • Maintained accurate records for all HACCP programs and audits.
  • Executed laboratory testing and maintained QA equipment to ensure reliable results.
  • Assisted in developing audit and testing procedures to enhance quality systems.
  • Analyzed samples and documented findings supporting regulatory and internal quality initiatives.
  • Ensured accurate QA records aligned with company and regulatory standards.

Quality Control Inspector

Custom Fruit and Flavors
Irwindale, CA
10.2015 - 11.2017
  • Executed first article and in-process inspections to ensure compliance with specifications.
  • Conducted rigorous testing of new products using diverse equipment per strict guidelines.
  • Managed product lifecycle from initial trials to successful transfer to manufacturing.
  • Read and plated 3M Petri film plates for microbial testing purposes.
  • Authored comprehensive non-conformance reports, resulting in reduced production errors.
  • Developed quality control plans aligned with technical documentation and production needs.
  • Performed inspections and testing on raw materials and finished goods for quality assurance.
  • Communicated quality findings to production staff and leadership to facilitate corrective actions.

Clinical Experience

Arizona College of Nursing
Ontario, California
02.2024 - 12.2025

NUR 215L – Fundamentals of Nursing | 144 Clinical Hours | Brookdale Senior Living | April – August 2024

NUR 355L – Medical-Surgical Nursing I | 144 Clinical Hours | Upland Rehabilitation & Care Center – Medical-Surgical Unit | August – December 2024

NUR 356L – Mental Health Nursing | 96 Clinical Hours | Shandin Hills Behavioral Health | August – December 2024

NUR 425L – Medical-Surgical Nursing II | 144 Clinical Hours | Riverside Community Hospital – Medical-Surgical & Telemetry Units | December 2024 – April 2025 |

NUR 426L – Community Health Nursing | 144 Clinical Hours | Illumination Foundation | December 2024 – April 2025

NUR 335L – Obstetric Nursing | 96 Clinical Hours | Pomona Valley Hospital Medical Center – Labor & Delivery | May – August 2025

NUR 336L – Pediatric Nursing | 96 Clinical Hours | Pomona Valley Hospital Medical Center – Pediatric Unit | May – August 2025

Education

Bachelor of SCIENCE - Nursing

Arizona College
Ontario, CA
12.2025

Associate of Science - Math and Science

Chaffey College
Rancho Cucamonga, CA
12.2018

Skills

  • Regulatory Compliance (FDA, GMP, GDP, ISO)
  • Quality Systems & CAPA
  • Audit Readiness & Inspection Support
  • Customer Complaint Investigations
  • Root Cause Analysis (RCA)
  • SOP Review & Technical Documentation
  • Process Improvement & Risk Mitigation
  • Equipment Calibration & Validation
  • Data Analysis & QA Reporting
  • Cross-Functional Collaboration
  • Quality Data Analysis & Reporting
  • Test Planning & Protocol Validation
  • Equipment Calibration & Verification
  • Measurement Accuracy & Data Integrity
  • Information & Document Verification
  • BLS
  • Stop the Bleed

Certification

American Heart Association BLS

Accomplishments

Honors - Arizona College of Nursing

Timeline

Clinical Experience

Arizona College of Nursing
02.2024 - 12.2025

Quality Assurance Specialist

KC Pharmaceuticals
12.2023 - 05.2025

Regulatory Compliance/Quality Assurance Analyst

Orchid
09.2022 - 12.2023

Manufacturing Technician II

Gilead
10.2019 - 09.2022

Quality Assurance Technician

Nellson Nutraceutical
12.2017 - 07.2019

Quality Control Inspector

Custom Fruit and Flavors
10.2015 - 11.2017

Bachelor of SCIENCE - Nursing

Arizona College

Associate of Science - Math and Science

Chaffey College
Kimberly Postakis Lambertinis