Summary
Overview
Work History
Education
Skills
Timeline
Generic

William Andrew Hawley II

Fuquay-Varina

Summary

Detail‑oriented Quality Control Specialist with three years of biopharmaceutical experience and a strong track record of compliance, safety leadership, and cross‑functional collaboration. SME in raw material sampling, documentation review, GDP, and regulated storage practices. Active contributor to site Safety Committee and trained first responder through MERT. Known for creating compliant processes, training staff, eliminating communication gaps, and consistently achieving 100% turnaround and RFT accuracy targets. Seeking to leverage operational safety, risk reduction, documentation expertise, and incident response experience in an EHS&S Specialist role at Merck.

Overview

4
4
years of professional experience

Work History

Quality Control Raw Materials Specialist I

KBI Biopharma
02.2025 - Current

• SME for sampling, raw material review, documentation review, and shipping.
• Liaison between the QC team and third‑party testing laboratories, eliminating miscommunication and improving turnaround consistency.
• Review LIRs and prepare/present DTRs for OOS or process concerns; support Deviation Investigations during high workload periods.
• Lead and delegate tasks to Associate I and II staff; maintain 100% on‑time performance for 25‑day testing turnaround and 7‑day consumable review targets.
• Achieved the only 100% RFT accuracy for review of consumables and raw materials in team history (twice).
• Represent QC during audits as SME for sampling and retain procedures.
• Active Safety Committee member since 2022; participate in monthly reviews of incidents and near misses with EHS&S.
• Certified medical emergency responder (MERT), providing on‑site first response since 2023.

Quality Control Raw Materials Associate II

KBI Biopharma
02.2024 - 02.2025

• Sampling lead responsible for training new personnel on documentation, gowning, staging, sampling, material review, and third‑party shipping processes.
• Trained staff on receiving and evaluating external lab results for QC release.
• Designed complete retain‑sample process across all material classes (ambient, cold, acids, bases, flammables).
• Created compliant storage locations and coordinated long‑term third‑party retain storage per NC Fire Codes.
• Authored SOP for retain storage and management; established SME status for safe movement and storage of retain samples.
• Organized and tracked all retain samples to ensure regulatory readiness.

Document Control Coordinator I

KBI Biopharma
08.2023 - 02.2024
  • Coordinated document control processes to ensure compliance with industry regulations and company standards.
  • Implemented filing systems for effective retrieval and tracking of documents across departments.
  • Reviewed and revised standard operating procedures to enhance clarity and accuracy.
  • Collaborated with cross-functional teams to maintain up-to-date documentation throughout project lifecycles.
  • Led department-wide training sessions in quality control techniques and practices.
  • Reviewed and revised documents adhering to specific requirements and deadlines for international
    clients.

QC Associate

KBI Biopharma
08.2022 - 08.2023
  • Operated material handling equipment to facilitate efficient inventory management
  • Assisted in the receiving and inspection of incoming materials for quality assurance
  • Collaborated with team members to streamline workflow processes in material handling
  • Supported shipping and packing operations by preparing materials for distribution
  • Followed safety protocols to maintain a secure work environment
  • Performed daily floor walks and supervised receive docks to investigate and resolve material issues.

Education

Bachelor of Science - Business Communication

East Carolina University
Greenville, NC
05-2020

Skills

    EHS&S practices and safety culture


    Risk assessment and mitigation


    Incident reporting, DTRs, LIRs, deviations


    GDP and GMP compliance


    SOP authorship and document control


    Process creation and improvement


    Raw material sampling & review (SME)


    Cross‑functional communication


    Training and team leadership


    Emergency response (MERT)

Timeline

Quality Control Raw Materials Specialist I

KBI Biopharma
02.2025 - Current

Quality Control Raw Materials Associate II

KBI Biopharma
02.2024 - 02.2025

Document Control Coordinator I

KBI Biopharma
08.2023 - 02.2024

QC Associate

KBI Biopharma
08.2022 - 08.2023

Bachelor of Science - Business Communication

East Carolina University
William Andrew Hawley II