Thomas Loder
Environmental Monitoring and Compliance Lead, Sterile & Liquids Pilot Plant
- Role
- Environmental Monitoring and Compliance Lead, Sterile & Liquids Pilot Plant at Merck
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
Experience
Environmental Monitoring and Compliance Lead, Sterile & Liquids Pilot Plant
Aug 2023 — Present
Lead, coach, and mentor the personnel within the group, in addition to ensuring that all staff are appropriately trained to complete assigned tasks- Annually support development and execution on SLP IPT strategy and objectives- Manage and delegate and drive execution of classified facility, utility, and aseptic processing area EM Program requirements- Lead compliance improvement projects and change management projects that support the facility’s EM program and sterility assurance- Develop and communicate action and remediation plans to senior management for gap closure of current practices- Ensure timeline completion of the authoring, review, and approval of GMP procedures and documentation- Support and drive the completion of quality risk assessments, potent compound handling risk assessments, and follow up activities to enable safe and compliant handling of potent drug products- Lead the internal audit program, including the detailed planning with significant collaboration with the Quality organization- Actively participate in quality and compliance forums- Lead, facilitate and/or participate in Notice of Event (NOE) reporting, investigations, and any related corrective action/preventive action- Lead or facilitate equipment/system changes, execution of periodic reviews and support of Quality Management System (QMS) activities
Education
West Virginia University
Bachelor of Science (B.S.)
Skills
- Interpersonal Communication
- Management
- Engineering
- Wireline
- Validation
- Quality System Compliance
- Preventive Maintenance
- Microsoft Excel
- Training and Devolpment
- Safety Compliance
- Isolators
- Change Control
- Preventative Maintenance
- Troubleshooting
- Aseptic Processing
- Supervision
- Completion
- Gmp
- Sop Development
- Microsoft Office
- Pharmaceutical Industry
- Fda
- Field Operations
- Energy
- Customer Service
- Aseptic Technique
- Gas
- Regulatory Affairs
- Supervisory Skills
- Oil & Gas
- Leadership
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