
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.
• 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.
• 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.
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)