Scope of Position

Ensure safety, industrial hygiene (IH), and environmental policies and procedures are upheld by working closely with management personnel and employees at all levels to further develop the facility's Safety and Environmental Systems.

Responsibilities

• Enhance Safety Culture, ensuring programs are designed and delivered to include all employees.
• Establish an EHS Dashboard which is accessible to all employees.
• Implements and maintains applicable SOPs to ensure compliance with OSHA and MOSH regulations.
• Conducts inspections and audits; investigates incidents and drives accountability to resolve issues.
• Provides training material for departmental training and performs corporate training.
• Maintains SDS inventory.
• Coordinates with toxicologist for OEL/ ADE reports; assesses proper engineering controls; writes handling instructions for the API/ product.
• Prepares and maintains all EHS documentation and reporting deadlines and communicates with governmental agencies.
• Monitors federal, state, and municipal regulatory changes to ensure future compliance. Serves as a primary liaison between this location and regulatory entities when required.
• Ensures compliance with county, state, and federal regulations.
• Air and Water Monitoring and Regulations.
• Oversees proper handling and disposal of all Waste (non-hazardous, hazardous, universal, and biohazardous).
• Arrange IH air monitoring of manufacturing rooms and containment equipment; review data; write summary reports when required.
• Coordinates with toxicologist for OEL/ADE reports; maintains databases for all relevant API information.
• Maintains clean ability assessment reports and F1073 (list of API cleaning categories).
• Provides support for QRMP reports to assess and manage risk for cross-contamination.
• Provides analysis and interpretations of EHS findings and prepares technical plans and reports as required.
• Generates, maintains, and files all necessary records and reports relevant to EHS.
• Responsible for communicating all relevant EHS to management and employees.
• Perform other duties as assigned.

Qualifications

• BS in chemistry or related physical/biological science, or equivalent combination of education, training, and professional experience.
• Minimum of five (5) years of EHS experience in an industrial/manufacturing environment.
• Pharmaceutical experience preferred.
• HAZMAT certified.
• Strong math and writing skills.
• Familiar with Air permit compliance is a plus.
• Strong analytical ability is required to gather and summarize data for reports, find solutions to various EHS issues, and prioritize work.
• Familiar with laboratory and manufacturing operations.
• Ability to interpret and relate Quality standards for implementation and review.
• Knowledge of Quality principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
• Must be able to comprehend and follow all applicable SOPs.
• Knowledge / Experience with electronic Quality Management Systems such as MasterControl
• Solid understanding of current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Good understanding of cGMPs, industry, and regulatory standards and guidelines.
• Familiarity with Microsoft programs, such as Word, Excel, PowerPoint, Access, Project, etc.
• Ability to always portray an appropriate level of integrity and professionalism.
• Ability to communicate effectively with management, staff, regulators, and client representatives in both written and verbal forms.
• Ability to complete tasks accurately and according to established timelines.
• Energetic, self-motivated, and organized individual accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
• Results-oriented and efficient.
• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
• Ability to work closely with a diverse customer and employee base (internally and externally).
• Ability to work well in a cross-functional team environment.
• Must communicate fluently in English and have legible handwriting.