Winston Woodfork
Indianapolis,IN
Summary
Results-oriented Pharmaceutical Sciences professional with expertise in aseptic technique, gowning qualifications, and contamination control strategies. Led root-cause investigations and CAPA execution for environmental monitoring alerts across ISO 7 cleanroom suites, achieving zero repeat excursions. Strong background in translating microbiological data into effective contamination prevention controls aligned with FDA cGMP and EU standards.
Overview
5
5
years of professional experience
Work History
Sterility Assurance Lead
Ossium Health
Indianapolis, Indiana
11.2025 - Current
- Root Cause Investigations & Deviation Management: Served as the primary technical investigator for environmental monitoring alert and action limit excursions across viable air, surface, and particulate monitoring locations; utilize formal RCA tools (5 Whys, Fishbone) to isolate root causes and evaluate direct product quality
impact. - CAPA Execution & Measurable Impact: Designed and implemented targeted
corrective and preventive actions (CAPAs)—including optimized cleanroom sanitization intervals, modified material transfer airlock procedures, and enhanced
personnel qualification—achieving zero repeat environmental monitoring excursions
over 12 consecutive months across critical cleanroom suites. - Contamination Control Strategy (CCS) Execution: Owned and refined the site-wide
Contamination Control Strategy in alignment with EU Annex 1/ISO 14644-1, identifying bioburden risks, optimizing personnel and material flows, evaluating airlocks, and enhancing cleanroom sporicidal sanitization routines. - Environmental Monitoring Trending & Analytics: Directed the site Environmental
Monitoring (EM) program across ISO 7 cleanrooms; compiled and presented quarterly and annual statistical trend evaluations, analyzed recovered isolate flora patterns, and identified shifts in environmental control before deviations manifest. - Aseptic Gowning Qualification Program: Established, administered, and supervised
comprehensive aseptic gowning qualification and periodic requalification protocols for manufacturing, QC, and support staff, utilizing strict visual rubrics and post gowning microbiological surface monitoring (gloves, sleeves, hood, chest). - Aseptic Technique Oversight & Floor Audits: Conducted routine cleanroom floor
compliance audits to ensure strict adherence to aseptic behavior, unidirectional laminar airflow discipline, cleanroom hygiene, and non-intrusive operational
standards. - Cross-Functional TS/MS Partnership: Partnered proactively with Manufacturing
Operations, Quality Control Microbiology, Facilities Engineering, and Quality
Assurance to resolve floor anomalies, support process modifications, and drive
technical contamination mitigation projects.
Floor Supervisor
Ossium Health
Indianapolis, IN
11.2024 - 11.2025
- Cleanroom Operations & Compliance: Supervised day-to-day operations in active
cGMP cleanrooms, maintaining strict adherence to aseptic techniques, gowning
requirements, and standard operating procedures (SOPs). - Operator Qualification & Onboarding: Partnered with Sterility Assurance to guide
new manufacturing staff through hands-on gowning training, material surface
sanitization transfers, and aseptic core operational behaviors. - Workflow Optimization: Facilitated regular cross-functional review meetings to
identify operational bottlenecks and contamination risks, implementing scheduling
and staging enhancements that improved overall workforce efficiency by 15%. - Floor Incident Escalation: Acted as frontline technical liaison during floor
discrepancies, stabilizing operations, segregating suspect materials, and
coordinating immediate containment with QA.
Production Associate
Ossium Health
Indianapolis, Indiana
11.2021 - 11.2024
- Aseptic Manipulation & Processing: Performed clinical-grade cell therapy
manufacturing manipulations inside ISO 5 biological safety cabinets and laminar
flow environments, maintaining strict aseptic barrier control and achieving zero
operator-related contaminations. - Personnel Monitoring & Record Execution: Performed routine post-processing
personnel monitoring (finger dabs and sleeve contact plates) and executed real-time
documentation in accordance with strict Good Documentation Practices (GDP) and
cGMP standards. - Procedure Optimization: Drafted and refined operating procedures centered on
sterile component staging and line clearance, assisting in onboarding and mentoring
peer associates on aseptic manipulations.
Education
Bachelor of Science - Pharmaceutical Sciences
PURDUE UNIVERSITY- SCHOOL OF PHARMACY
West Lafayette, IN05-2020
Skills
- Aseptic Processing & Contamination Control: Critical Zone (ISO 5)
Unidirectional Airflow Protection, First Air Principles, Aseptic Manipulation,
Contamination Control Strategy (CCS), Cleanroom Disinfection & Sporicidal
Regimens - Gowning Qualification & Personnel Training: Aseptic Gowning Protocols, Visual &
Microbiological Gowning Qualification/Requalification, Personnel Surface Monitoring
(Glove & Garment Contact Plates), Cleanroom Behavioral Auditing - Environmental Monitoring & Data Trending: Viable Air & Surface Sampling, Non
Viable Particulate Monitoring, Critical Utility Monitoring, Statistical Trend Analysis,
Alert/Action Level Management, Microorganism Identification & Flora Profiling
- Deviation Management & CAPA Leadership: Root Cause Analysis (Fishbone/5 Whys), EM Alert & Action Limit Excursion Investigations, Out-of-Trend (OOT)
Assessments, CAPA Design & Effectiveness Checks, Recurrence Elimination, Risk
Assessments (FMEA) - TS/MS & Sterility Assurance Oversight: Manufacturing Process Support, Technical
Deviation Closure, External/Internal Audit Preparedness, Standard Operating
Procedure (SOP) Authoring, cGMP Compliance (EU Annex 1, USP <1116>, USP <71>)
Timeline
Sterility Assurance Lead
Ossium Health
11.2025 - Current
Floor Supervisor
Ossium Health
11.2024 - 11.2025
Production Associate
Ossium Health
11.2021 - 11.2024
Bachelor of Science - Pharmaceutical Sciences
PURDUE UNIVERSITY- SCHOOL OF PHARMACY