Nature and Scope
The Environmental Specialist is responsible for implementing and maintaining the Environmental programs in an FDA regulated pharmaceutical manufacturing environment. The position will be responsible for identifying and implementing strategies to address industrial hygiene, chemical regulatory safety requirements, environmental regulatory compliance, as well as responsibilities for the preparation of all federal, state, and local filings for all American Regent Facilities.
Essential Duties and Responsibilities
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
Manage Environmental, Health and Safety processes:
- Prepare, maintain, and assure compliance to procedures for the EHS systems and associated processes adhering to cGMPs, OSHA, EPA, and all company applicable local and state requirements.
- Implement and maintain compliance with all ISO14001 requirements.
- Perform risk assessments for manufacturing of cytotoxic and high potent compounds, assessing OEL/OEBs.
- Assist with completion of all safety Risk Management assessments for all facilities including insurance, regulatory, and safety liabilities.
- Develop safety workplans including JHAs outlining process controls, PPE requirements, and proper waste handling requirements.
- Evaluate facility environmental, health and safety conditions, assess risks and develop appropriate corrective action plans to address deficiencies in comparison to regulations, best in class industry standards, and company policy.
- Conduct Hazardous Drug Assessments and chemical hazard assessments identifying PPE requirements and controls ensuring adequate chemical hygiene throughout operations.
- Provide environmental guidance and compliance support to both executive and local site management to ensure ongoing compliance to regulatory and organizational requirements.
- Manage and oversee environmental-training requirements including HAZCOM, chemical hazard assessments, and environmental compliance programs, etc.
- Compile and maintain all required records for environmental reporting including EPA, NYSDEC, City of Columbus, California, etc.
- Develop, review, and update ARI safety data sheets for current and future product lines.
- Update and manage Hazard Communication database including chemical purchasing approvals, associated chemical hazard assessments, and other HAZCOM requirements.
- Partner with Area Management assuring compliance to chemical inventories, Hazard Communication, storage and material transfer.
- Companywide waste management including regulatory reporting (Annual waste reports, semi-annual waste reports, Waste minimization plans/updates, e-manifests, etc.)
- Update and review of ARI waste profiles and waste management procedures/policies, ensuring implementation of adequate systems to maintain compliance to waste storage and handling requirements, assure certification.
- Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
- Bachelor's degree in Occupational Health & Safety, Engineering, or related field technical EHS (OSHA) certification preferred.
- Certified Industrial Hygienist (CIH) required.
- Minimum of 5 years EHS compliance and program experience.
- Must have working knowledge of ISO14001 standards and requirements.
- Must have working knowledge of U.S. and Federal EHS regulations and standards, and demonstrated effective interaction with regulatory agencies (EPA, OSHA, etc.).
- Must be proficient in the use of Microsoft Office Applications, including Microsoft Project, Word, and Excel.
- Must have good interpersonal relationship skills, strong project management and process improvement skills, as well as strong cross-functional teamwork skills. Must be able to think outside of the box.
- Effective written oral and written communication skills, acute attention to detail, excellent time management.
- Role models Can Do attitude. Reinforces positive approach in daily group activities. Readily adapts to changing job duties. Establishes culture that emphasizes responsiveness.
- Travel Required up to 30%.
Physical Environment and Requirements
- Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.
- Employee must be able to occasionally lift and/or move up to 50 pounds.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
Applicants have rights under Federal Employment Laws.
- FMLA poster:
- Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
- Employee Polygraph Protection Act:
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