Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Generic

Lauren Bentley

Lenoir,NC

Summary

Detail-oriented and highly organized Quality Assurance Operations Technician with 4 Quality Assurance and 6 Operational years of experience ensuring compliance with industry standards, regulatory requirements, and internal quality systems. Skilled in executing quality checks, monitoring production processes, performing audits, and supporting continuous improvement initiatives. Adept at using QA tools, maintaining documentation, and collaborating across departments to uphold product integrity and operational efficiency. Proven ability to identify root causes of quality issues and drive corrective actions in fast-paced, regulated environments.

Overview

10
10
years of professional experience

Work History

Quality Assurance Operations Technician- Group Lead

Exela Pharma Sciences
02.2024 - 05.2025
  • Proficient in performing business transactions within SAP, including data entry, reporting, and workflow
  • Conduct manual inspection qualification tests to assess and certify personnel competency
  • Advanced Excel user with strong proficiency in Microsoft Office applications (Word, PowerPoint, Outlook).
  • Experienced in reviewing and updating Standard Operating Procedures (SOPs), forms, and related documentation for accuracy and compliance.
  • Conduct quarterly reviews of pest control logbooks to ensure compliance with regulatory and company standards.
  • Conduct QA reviews of operations logbooks to ensure accuracy, completeness, and compliance with SOPs and regulatory standards.

Quality Assurance Operations Technician

Exela Pharma Sciences
07.2021 - 02.2024
  • Inspecting and approving incoming medications and raw materials by confirming specifications
  • Knowledge and experience in handling raw materials in and out of cleanrooms
  • Updating job knowledge by reading SOP’s and practicing GDP as well as cGMP
  • Conducting visual and measurement tests of different medications
  • Rejecting and returning unacceptable materials
  • Communicating necessary adjustments to production supervisor and necessary staff
  • Documents inspection results by completing reports and logs as well as documentation of re-work and waste
  • Inputting data into Quality logbooks and database
  • Maintains a safe work environment by following SOP’s and complying with legal regulations
  • Performed acceptable quality limit for visual inspection on finished drug product

SD/SEV Aseptic Lead

Stallergenes Greer
01.2020 - 07.2021
  • Investigate/Write Deviations.
  • Trainer for all Aseptic rooms
  • Collaborate as a member of cross-functional teams
  • Perform backflushing/transactions within JDE
  • Perform weekly and monthly metrics
  • Type 3 and Type 4 Garb Qualifications
  • Lead of 10 plus employees

SD/SEV Sterile Technician

Stallergenes Greer
07.2015 - 07.2021
  • Type 4 Garb Certification
  • Participation in Media Fills
  • Perform Mixing Formulation/Crimping/Filling activities
  • Collaborate as a member of cross-functional teams
  • Use of Aseptic Technique
  • Trainer of all aseptic activities

Education

High School Diploma -

West Caldwell High School
Lenoir, NC
06-2013

Skills

  • Investigate/Write Deviations
  • Proficient in Microsoft Office, Excel, Word, Power Point, JDE, SAP, Veeva Vault and Master Control systems
  • Over 10 years of experience working in GMP in pharmaceuticals
  • GMP/GDP Compliance
  • Root Cause Analysis

Accomplishments

    DACUM Training Certified

    Type 3 and Type 4 Garb Certified

    RCRA Certified

    Blood Borne Pathogen Certified

Timeline

Quality Assurance Operations Technician- Group Lead

Exela Pharma Sciences
02.2024 - 05.2025

Quality Assurance Operations Technician

Exela Pharma Sciences
07.2021 - 02.2024

SD/SEV Aseptic Lead

Stallergenes Greer
01.2020 - 07.2021

SD/SEV Sterile Technician

Stallergenes Greer
07.2015 - 07.2021

High School Diploma -

West Caldwell High School

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