Provide overall direction and oversight of EHS and Regulatory Compliance affairs of the organization. Responsible for development, design, implementation, and measuring performance monitoring of EHS and Compliance programs. In addition, responsible for developing procedures to verify that organization meets industry codes and standards and other specified requirements. Oversee risk management and process improvement as it relates to compliance with OSHA, EPA, DOT, FDA Good Manufacturing Practices (GMP) and other applicable standards, regulations, and internal procedures.
Duties & Responsibilities: Provide leadership to ensure the standard of performance is achieved and sustained including: compliance training, environmental compliance and reporting to Federal, State and Regulatory Agencies Design and implementation of a new EHS management system, to ensure a decrease in safety incidents and create a culture of continuous improvement by engaging employees at all levels of organization Development and implementation of comprehensive training programs for all employees on health & safety regulations, hazard recognition, incident investigation, and root cause analysis Define scope and implementation of new protocols and procedures to ensure compliance with federal/state regulations, as well as OSHA, EPA, FDA (cGMP) requirements KPIs development, monitoring and timely reporting to Executive Leadership and upper Management Teams Development & implementation of risk management program to ensure employees' and leaders' safety, address potential risks and develop reliable solutions and compliance with applicable Regulatory Standards Developed and oversee of incident /non-conformance reporting and CAPA management program including, but not limited to, root cause analysis and continuous improvement strategies Responsible for facilitation of Suppliers/3rd Party and Regulatory audits and inquiries. follow-up with corrective action, written responses, and appropriate documentation & reporting
DMS/SOP management (development, implementation, training and review of company's Standard Operating Procedures , Policies and related documentation) OSHA & Federal Compliance reporting (including but not limited to OSHA 300, Fire Inspections, DOT/State/FDA Registrations) Development and implementation of comprehensive EHS Compliance Inspection & Auditing program Collaborate with HR to Manage on-site RTW (Return to Work) program & Workers' Compensation claim processing. Lead accident/injury investigation by evaluating and analyzing accident reports, OSHA logs, Workers' Compensation claims as well as related data and trends to establish root cause analysis and prepare recommendations for preventions Determine recommendations to reduce workplace hazards by improving PPE gear, implement administrative and engineering controls to address behavioral, physical and environmental contributing factors through continuous improvement process Give guidelines and facilitate compliance solutions and interdepartmental guidance to assure compliance with local, state, and federal regulations or customer standards Chair of the organization's Safety Committee for risk minimization actions, site corrective actions and for conforming to government contract requirements and integrating business operations with EH&S objectives while performing these activities in a cost-effective manner Development and oversee of tracking and analyzing company's Sustainability Efforts – Companywide compilation of data for Carbon Footprint Calculations for electricity, recycling, water use, and Green House Gasses emission. Established Recycling program to reduce company overall CO2 emissions Design and oversee implementation of IMS (integrated management system) to ensure process standardization and compliance alignment with ISO:9001, ISO:14001, ISO:45001 and FDA standards as applicable to industry requirements Participate in New Client Product reviews to review product designs for compliance to standards, operations controls and inspection methods and reporting Strong Business Partner with our 3rd Party Vendors, Controller and internal General Managers Qualifications / Skills: Bachelor's degree (Business, Occupational Health & Safety or Process Engineering) with min 10 years of experience with managing/oversee EHS Compliance programs in manufacturing /distribution/warehousing/3PL Preferred experience working with commercial, FDA cGMP, Health Canada (or other high-tech QA/QC Standards and EHS Standards) Strong emphasis in compliance for Audits, FDA, other regulator state and federal requirements Preferred Certification: ISO, cGMP, HACCP, HAZMAT/DOT or other Quality and/or Safety Certification Must be proficient in MS Office, especially Microsoft Excel, Word and PowerPoint Must have strong attention to detail and accuracy Excellent communication & leadership skills required. Must be able to interact with various levels within the organization
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