Joshua Leak
WINTERVILLE,NC
Summary
Results-driven professional with 15+ years of experience in pharmaceutical manufacturing and documentation within highly regulated environments. Skilled in administrative support, compliance, and record management, with a strong foundation in manufacturing operations, equipment troubleshooting, and cGMP standards. Recognized for training, organization, and cross-functional communication. Seeking an Administration role at Thermo Fisher while leveraging manufacturing expertise to support compliance and operational excellence.
Overview
23
23
years of professional experience
Work History
Formulation Technician
Thermo Fisher Scientific
04.2021 - Current
- Ensure pharmaceutical products are manufactured in compliance with SOPs and cGMP.
- Maintain accurate documentation in batch records, logbooks, and controlled forms.
- Perform equipment setup, filter integrity testing, line changeovers, and aseptic filling operations.
- Troubleshoot alarms and equipment issues to minimize downtime.
- Review batch records for accuracy and regulatory compliance.
- Self-motivated, with a strong sense of personal responsibility.
Environmental Servicer
Thermo Fisher Scientific
04.2016 - 04.2021
- Oversaw sanitation and compliance documentation for production lines.
- SME Certified Trainer for Environmental Cleaning SOP; trained and mentored new staff.
- Documented GMP cleaning activities for audits and inspections.
- Contributed to safety programs and lean manufacturing initiatives.
Production Operator
Hospira
08.2008 - 05.2014
- Operated packaging and inspection equipment; documented results in compliance with SOPs.
- Assisted with troubleshooting production and documentation discrepancies.
- Performed product inspections to ensure packaging and labeling accuracy.
Material Handler
Unican Kabail
01.2003 - 05.2008
- Verified and documented materials for production orders.
- Prepared shipping documentation and coordinated logistics.
- Operated mobile equipment to manage material flow.
- Additional roles in Security & Transportation available upon request
Education
Associate of Applied Science - Information Technology: Cybersecurity
Pitt Community College
Winterville, NC05-2027
Skills
- Documentation & Record Management
- Administrative Support & Compliance
- Manufacturing Operations & cGMP Standards
- Equipment Setup & Troubleshooting
- Batch Record Review
- Training & Staff Development
- Quality Assurance & Inspection
- Communication & Coordination
Timeline
Formulation Technician
Thermo Fisher Scientific
04.2021 - Current
Environmental Servicer
Thermo Fisher Scientific
04.2016 - 04.2021
Production Operator
Hospira
08.2008 - 05.2014
Material Handler
Unican Kabail
01.2003 - 05.2008
Associate of Applied Science - Information Technology: Cybersecurity
Pitt Community College
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