Sarah Livingston
Old Fort
Summary
Pharmaceutical manufacturing professional with 7+ years of hands‑on experience, recognized for strong problem‑solving skills, adaptability, and a proactive, results‑driven approach. Brings creativity and resilience to new challenges and is committed to contributing meaningfully to organizational goals.
Overview
8
8
years of professional experience
Work History
Lead Investigator - Quality Control
Baxter International Inc
Marion, NC
11.2023 - Current
- Lead targeted and large-scale quality investigations involving manufacturing operations, equipment, and critical systems using DMAIC and Six Sigma methodologies to determine root cause and define corrective and preventive actions (CAPA).
- Author technically rigorous investigation reports supported by objective evidence, product impact assessments, and regulatory justifications.
- Independently manage competing workloads and investigation timelines while maintaining compliance with cGMP requirements.
- Facilitate cross-functional teams to drive investigation execution and corrective action implementation.
- Perform quality and aseptic process assessments of manufacturing activities, personnel practices, and equipment; initiate and support immediate corrective actions.
- Provide regulatory inspection and audit support, including preparation of investigation packages and direct interaction with auditors.
- Trained junior investigators on best practices for conducting thorough and efficient investigations.
Senior Quality Assurance Associate
Pfizer
Sanford, NC
05.2018 - 11.2023
- Prepared investigation reports that integrated technical findings, product‑impact assessments, and regulatory requirements.
- Performed batch record and manufacturing documentation review and disposition.
- Led and participated in Kaizen events to identify systemic trends, close process gaps, and strengthen risk‑assessment strategies that drive continuous improvement aligned with Six Sigma.
- Created and revised SOPs, work instructions, raw‑data and batch‑record documentation tools, and job aids to resolve process bottlenecks, enhance documentation integrity, and strengthen sustained compliance.
- Provided quality oversight of manufacturing processes and evaluated execution of cGMP practices in alignment with EU GMP Annex 1 and 21 CFR Part 211.
Education
Bachelor of Science - Biology
University of North Carolina At Asheville
Asheville, NC05-2012
Skills
- Technical and Regulatory Writing
- Root Cause Analysis (DMAIC, Six Sigma)
- CAPA Strategy and Governance
- Regulatory Inspection and Audit support
- Cross Functional Team Leadership
- Independent Project Management
- Adaptability in Fast-Paced Environments
- Quality Systems (LIMS, Veeva, SAP, TrackWise, Maximo, Historian, Cognos, QMS)
- Microsoft Office (Word, Powerpoint, Excel)
Timeline
Lead Investigator - Quality Control
Baxter International Inc
11.2023 - Current
Senior Quality Assurance Associate
Pfizer
05.2018 - 11.2023
Bachelor of Science - Biology
University of North Carolina At Asheville