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RAJESH SHOB
Aurora,CO
Summary
EHS-focused professional with a Master of Science in Environmental Policy & Management and hands-on experience in cGMP, FDA, OSHA, and ISO 14001 compliance within a sterile pharmaceutical manufacturing environment. Selected to a site Safety Committee within weeks of hire. Skilled in hazard identification, deviation support, SOP adherence, and regulatory frameworks including RCRA, CWA, CAA, and NEPA. OSHA 30-Hour General Industry certified.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Safety Committee Member
Leiters Health
Englewood, CO
07.2025 - Current
- Selected within first month of hire to represent the Visual Inspection & Labeling/Packaging department on the site Safety Committee, recognized for safety awareness and peer credibility.
- Conduct routine safety observations and walk-throughs covering equipment guarding, ergonomics, chemical handling, and workflow design; document and escalate hazards through the committee process.
- Partner with leadership and EHS stakeholders on corrective actions, SOP updates, and behavior-based safety initiatives, reinforcing a proactive safety culture across shifts.
Visual Inspection and Packaging Associate
Leiters Health
Englewood, CO
06.2025 - Current
- Execute visual inspection, labeling, and packaging of sterile compounded pharmaceuticals in full compliance with cGMP, FDA 21 CFR 210/211, and site SOPs, supporting the facility's product quality and patient safety obligations.
- Perform line and area clearance prior to every inspection and labeling run to prevent product mix-ups, cross-contamination, and documentation errors, a critical control point in FDA-regulated operations.
- Identify and escalate labeling, documentation, and process deviations to the Lead and QA, supporting root-cause investigation, CAPA tracking, and timely deviation closure.
- Complete and reconcile batch inspection and packaging records during and after each activity, maintaining audit-ready documentation that withstands internal QA and regulatory review.
- Maintain strict adherence to gowning, cleanroom, and aseptic behavior protocols on 2nd-shift operations while sustaining inspection accuracy and throughput targets.
- Manage label and inspection material inventory accuracy to ensure on-time readiness for daily production schedules and reduce risk of line-clearance failures.
Resident Assistant
University of Denver-Housing & Residential Education
Denver, CO
08.2024 - 06.2025
- Served as a first responder and incident commander for a residential community, executing emergency response protocols, evacuations, and safety escalations under time pressure.
- Authored detailed incident reports and safety documentation, applying the same rigor and chain-of-custody discipline used in EHS investigations.
- Designed and delivered safety, sustainability, and policy-compliance programming for residents, building behavior-change skills directly transferable to EHS training and toolbox-talk delivery.
Environment Protection Officer
Rastriya Dalit Network, RDN Nepal
Kathmandu, Nepal
08.2021 - 01.2023
- Conducted regulatory site visits and compliance inspections covering waste management, pollution control, and water quality, equivalent in scope to RCRA- and CWA-style audits.
- Authored compliance documentation, inspection reports, and KPI tracking tools that became the basis for corrective-action plans negotiated with regulated facilities.
- Partnered with municipal authorities on compliance monitoring, enforcement follow-through, and stakeholder engagement, strengthening regulator-industry communication.
Sustainability and Waste Management Officer
Green Ranger Earth, Nepal
Kathmandu, Nepal
02.2019 - 07.2020
- Managed labeling and sorting of waste materials, ensuring accurate record-keeping and compliance with safety guidelines.
- Performed quality checks during community waste collection campaigns to ensure proper handling.
Education
Master of Science - Environmental Policy and Management
University of Denver- Professional Studies
Denver, CO06-2025
Bachelor of Science - Environmental Management
Pokhara University- SchEMS (School of Environmental Science and Management)
Kathmandu, Nepal08-2022
Skills
- Regulatory Compliance: OSHA 29 CFR 1910 (General Industry), FDA cGMP (21 CFR 210/211), RCRA, CWA, CAA, NEPA, ISO 14001
- Safety & Risk: Hazard identification, safety observations, ergonomic assessments, JSAs, incident reporting, root-cause support, corrective & preventive actions (CAPA)
- Environmental Programs: Hazardous waste management, EMS design, spill prevention, waste minimization, pollution control, environmental impact assessment
- Quality & GMP: Visual inspection, line/area clearance, label reconciliation, batch documentation, deviation support, gowning and cleanroom protocols
- Audits & Documentation: Internal audits, compliance inspections, SOP authoring support, EPA-style report writing, inspection logs
- Tools & Software: Microsoft Office (Excel, Word, PowerPoint), QGIS, SPSS, trend charting
Certification
- OSHA 30-Hour General Industry Safety and Health – NYC Construction Safety Training LLC July 2025
- CITI Program (Social & Behavioral Research Certification (Ethics, Federal Regulations, Conflict of Interest) October 2024
- Training of Trainers (ToT) – Climate Risk Assessment & Adaptation Design March 2023
Timeline
Safety Committee Member
Leiters Health
07.2025 - Current
Visual Inspection and Packaging Associate
Leiters Health
06.2025 - Current
Resident Assistant
University of Denver-Housing & Residential Education
08.2024 - 06.2025
Environment Protection Officer
Rastriya Dalit Network, RDN Nepal
08.2021 - 01.2023
Sustainability and Waste Management Officer
Green Ranger Earth, Nepal
02.2019 - 07.2020
Bachelor of Science - Environmental Management
Pokhara University- SchEMS (School of Environmental Science and Management)
Master of Science - Environmental Policy and Management
University of Denver- Professional Studies
RESEARCH EXPERIENCE AND PUBLICATION
- Capstone Project, University of Denver Improving RCRA Compliance in Small Auto Repair Shops in Larimer County, Denver, Colorado
- Researched enforcement gaps and compliance challenges under RCRA.
- Proposed behaviorally driven compliance tools and stakeholder engagement strategies.
- Graduate Research Project, University of Denver Hazardous Waste Management Program Design for DuPont, University of Denver
- Designed a full-scale hazardous waste compliance framework for DuPont aligned with RCRA, CAA, and CWA regulations.
- Recommended waste minimization strategies, emergency planning, and employee training to reduce environmental and legal risks.
- Collaborative EMS Development Project, University of Denver Environmental Management System (EMS) Design for Jim’s Auto Repair
- Co-developed a full ISO 14001-compliant EMS for an auto repair shop, integrating hazardous waste management, spill prevention, and compliance tracking.
- Led sections on staff training programs, environmental policy design, and regulatory documentation aligned with EPA, RCRA, and CWA standards
- Peer-Reviewed Research Paper: Shob, R., & Joshi, R. (2022). Impact of Variation in Monsoonal Rainfall and Temperature on Paddy Production and its Adaptive Strategies: A Case Study from Bhaktapur District of Nepal. ( https://doi.org/10.33002/nr2581.6853.050406)