Job description

Sagent Pharmaceuticals Raleigh, NC
Sr. Specialist, Environmental Health and Safety
The Sr. EH&S Specialist will manage and continuously improve the compliance programs in accordance with all applicable State and Federal regulations, corporate requirements, and other legal requirements to help protect the health and safety of employees, to protect the environment, and to minimize risks to the company. This position will manage a program to foster a culture of safety and environmental stewardship at the site. Duties may include outreach activities, messaging, leading committees, and working directly with Senior Management Team to drive the safety culture.

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Key Responsibilities*

• Manage the development, implementation, and monitoring of the site EHS programs. This position will be responsible for ensuring that the facility has implemented the required elements of our EHS programs and Accident and Incident Prevention Plans. This position will also identify additional opportunities within the facilities for safety improvements and work with the Site Leadership Team to develop the appropriate control mechanisms
• Manages the waste management and minimization programs including the processing of Hazardous, Non-Hazardous and Bio-Hazardous waste for disposal including rejected drug vials, used chemical containers, expired chemicals, pharmaceutical contaminated waste, and other pharmaceutical and facility wastes. Ensures the proper storage, handling, transportation, labeling, documentation, inventory, and manifesting of all wastes shipped offsite.
• Manages the environmental programs including the Indirect Discharge Permit monitoring, SPCC Plan, storm water permitting, air permitting, and refrigerant management.
• Manages the Incident Reporting and Management, OHSA Recordkeeping, Industrial Safety Programs, Ergonomics, Respiratory Protection, Hearing Conservation, Blood Borne Pathogens, and Personal Protective Equipment programs.
• Develops and maintains the Industrial Hygiene program and reviews the exposure to physical and chemical hazards. Interprets and reports the results of IH monitoring to employees and management, prepares reports and recommendations to management for improvement or risk minimization.
• Manages EHS inspections, Job Safety Analysis, Risk Assessments, and program audits of Production Areas, Laboratories, and Mechanical spaces. Responsibilities include following up on corrective actions arising from these assessment/reviews. Conducts accident investigations and keeps documentation and follow up on action plans to prevent recurrence.
• Makes recommendations to address improvements in managing EHS risk and is required to elicit cooperation of others through contacts between departments. Has regular contact with individuals internally and externally, such as outside regulatory officials, customers and vendors.
• Responsible for continuous improvement of the site EHS Program, site safety culture, and employee engagement in safety. This includes management of the site Safety Suggestion Program and responding to associates who submitted suggestions and working with other department leadership in assigning action items to address suggestions, audit findings, and incident Root Cause Analysis findings and action items. Responsible for leading the Site Safety Team and site First Aid Team.
• Works regularly with information which is considered restricted and would have impact if disclosed. This includes audit findings, accident and health related data (HIPPA), and Industrial Hygiene monitoring results.
• Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversees that processes are in cGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.
• Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.
• Currently this position has no direct reports.

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Requirements*

• 5-7+ years of EHS experience in a pharmaceutical or industrial manufacturing setting
• Bachelor's Degree in Environmental or Safety Sciences, Chemistry, Microbiology or Engineering or related field
• Requires detailed knowledge of and experience interpreting local, state, federal and corporate regulatory requirements
• Candidate must possess strong written and oral communication skills and organizational abilities.
• The position requires the ability to work independently while maintaining communication with all team members. This position requires teamwork, leadership, and influencing skills with a strong focus on customer service. Excellent communication skills, both written and verbal, are required. The incumbent must possess strong interpersonal skills, and must offer innovative and creative solutions to customer problems

Physical Requirements of the Role
Works regularly under desirable conditions of the office setting but has occasional exposure to moderately disagreeable features of noise, heat or production conditions. Occasionally requiring lifting and carrying less than 10 lbs, standing, walking, bending over, and repetitive use of legs are done occasionally.

Job Type: Full-time

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