Environmental Regulatory Coordinator

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Description

Job Summary:

The Environmental Regulatory Coordinator's responsibilities serves to bridge the gap between complex scientific operations and legal requirements by ensuring compliance with environmental regulations, company policies, and supporting sustainability initiatives. This role supports our ability to monitor environmental performance, manage waste programs, maintain records, and assist with audits and reporting to promote environmental stewardship and regulatory compliance.

Primary Responsibilities:

• Understand all applicable local, state, and federal environmental regulations pertaining to pharmaceutical manufacturing so as to ensure compliance.
• Coordinate the proper handling, storage, and disposal of hazardous, non-hazardous, biohazardous and other manufacturing waste.
• Maintain accurate environmental records, including waste manifests, permits, and inspection logs.
• Assist in preparing and submitting environmental reports to regulatory agencies.
• Conduct routine environmental inspections.
• Support environmental monitoring programs (air, water, etc).
• Provide training and guidance to staff on environmental policies and procedures.
• Support sustainability initiatives and continuous improvement efforts.
• Develop, track, and report quality metrics to support the Quality Investigations team in evaluating product-related quality events.
• Track new and pending local, state or federal environmental regulations using available resources.
• Maintain a current Safety Data Sheet (SDS) records.
• Collaborate with safety and security in facilitating compliance with environmental policies.
• Involved in the daily operations of wastewater pre-treatment plant and obtain state issued operators certifications.
• Read meters and gauges, monitor operational parameters remotely, operate valves, pumps, and motors associated with the process wastewater facility.
• Continually strive to improve methods of compliance to ensure the most efficient use of site resources including manpower.

Supplemental Functions:

• Performs other similar duties as required.

Requirements

Knowledge & Skills:

• Knowledge of environmental regulation (e.g., EPA, RCRA, DOT, Clean Water Act).
• Basic understanding of FDA regulatory frameworks covering both cGMP operations and 503B Outsourcing Facility requirements.
• Must strive for continuous improvement in all work activities and pay great attention to detail.
• Excellent communication, interpersonal, and technical writing skills.
• Strong organizational and problem-solving skills with the ability to manage multiple priorities in a fast-paced, regulated environment.
• Ability to drive continuous improvement initiatives while maintaining regulatory compliance.
• Proficient in Microsoft Word, PowerPoint, Microsoft Excel, Dot Compliance, FactoryTalk, etc.
• Willingness to comply with all safety requirements, including the use of PPE such as safety glasses, hearing protection, and protective gowning as required.
• Must be able to work Saturday and & Sunday as evident or required.

Education/Experience:

• Associates or Bachelor's degree in Environmental Engineering, Environmental Science, Physical or Life Sciences (or a related scientific discipline).
• Must be willing to sit for the level D Physical/Chemical or Biological Wastewater Treatment Licensing Examination within 90 days of employment and successfully obtain the required certification within one year of employment.
• Education may be substituted with experience and is otherwise negotiable.

Working Conditions / Physical Requirements:

• Combination of office and field work.
• The position requires the handling of regulated materials and use of personal protective equipment (PPE).
• It also requires sterile gowning and clean room certification.
• Position requires occasional working in industrial or outdoor environments, confined space occupancy, counting, standing, sitting, walking, pushing, pulling, talking, hearing, typing and lifting (up to 40 lbs.).