Biological Safety and Health Specialist III

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Primary Purpose of Organizational Unit: The Occupational and Environmental Safety Office (OESO) provides the focus for the administration of all safety programs to Duke University, Duke University Medical Center, and Duke University Health System.  OESO has the responsibility for developing institutional safety plans and policies; providing information and training to meet all regulatory requirements; providing technical consultation and guidance; conducting exposure and risk assessments; conducting safety audits; monitoring compliance with all safety policies; and investigating accidents, injuries, and reported unsafe conditions.

Specific to the Biological Safety Division: The Biological Safety Division provides biosafety and biosecurity oversight across Duke University, Duke University Medical Center, and Duke University Health System to protect personnel from biological hazards and support safe research, patient care, and institutional operations. Its scope includes research and clinical laboratories, high-containment facilities, animal research, clinical trials, patient care settings, and work performed by facilities and support personnel. Biological hazards include infectious agents, bloodborne and airborne pathogens, biologically derived toxins, recombinant and synthetic nucleic acids, and select agents and toxins. The Division develops and implements policies, exposure control plans, training, risk assessments, audits, and incident follow-up; provides technical consultation on containment practices, facilities, equipment, and biological materials management; and supports institutional biosafety review, select agent compliance, and oversight of research with dual use concerns. These activities are informed by applicable regulatory requirements and current safety guidelines and coordinated with institutional committees and partners to promote safe practices, prevent occupational exposures, and maintain compliance.

Primary Purpose of Position: To establish, promote, and maintain a safe work environment throughout all Duke laboratories (research and clinical). The Biological Safety Specialist uses the principles of recognition, prevention, control, and monitoring to assure employees use the proper techniques to protect themselves and others from the risks associated with exposure to biological agents.  The Specialist provides biological safety training and instruction to university and medical center personnel and performs a variety of duties related to the development and implementation of safety policies and programs.  

Work Schedule: Regular schedule is eight hours per day Monday through Friday, with after hours and weekend coverage by telephone and/or in-person response depending on the situation.

Reporting Relationship: Report directly to the Director of the OESO Biological Safety Division.

Duties and Responsibilities

• Under the general direction of the Division Director, this position has primary responsibility to ensure compliance with biosafety level 3 (BSL-3) laboratories with applicable policies, procedures, regulations and guidelines. Coordinates high-containment laboratory safety activities, including training, occupational health requirements, audits, emergency preparedness, and facility validation. Position will also assist with BSL-2+ and BSL-2 laboratories as needed.
• Serves as an Alternate Responsible Official (ARO) for the Duke Select Agent Program and assists the Responsible Official (RO) in fulfilling requirements of the Federal Select Agent Program, including personnel suitability, training, program reviews, documentation, and incident response. As needed, acts as the RO in the absence of the RO.
• Coordinates review and updates to the Tuberculosis Exposure Control Plan (TB ECP) and supports its implementation for laboratory and animal research personnel in conjunction with Employee Health and other stakeholders. Provides guidance on TB-related procedures, equipment, risk assessments, and exposure follow-up.
• Supports review, development, and implementation of the Bloodborne Pathogens Program Exposure Control Plan (BBP ECP) and related policies and procedures. Evaluates exposure information and recommends measures to reduce occupational exposure to biological hazards.
• Develops, delivers, and evaluates biological safety training for various audiences. Monitors training compliance and effectiveness, supports consistency across training programs, and provides training and mentoring to personnel as needed.
• Provides technical review and support for institutional oversight of biological hazards, including activities involving the Institutional Biosafety Committee (IBC), Institutional Animal Care and Use Committee (IACUC), and Institutional Review Board (IRB). Assists with committee activities, policies, and records as needed.
• Audits work areas in which personnel are potentially exposed to biological agents, evaluates compliance with applicable policies and standards, and recommends corrective actions.
• Reviews and develops standard operating procedures (SOPs), policies, safety manuals, protocols, and guidance related to biological hazards. Conducts risk assessments and provides recommendations for appropriate safety practices and controls.
• Provides guidance on the proper shipment of biological materials.
• Reviews construction drawings and renovation plans to identify and mitigate biological hazards. Provides technical input on facility engineering controls and equipment and participates in commissioning and validation activities as needed.
• Supports biological safety information systems, data analysis, records, and website content.
• Provides biological safety consultation to OESO divisions and institutional partners. Assists with Division activities, program improvements, and other duties as assigned by the Division Director.
• Provides after-hours coverage for the OESO spill response team.
• Must be able to successfully enroll and maintain compliance with the Federal Select Agent Program’s Security Risk Assessment (SRA) and Duke University’s Personnel Suitability Program.

Other Position Characteristics

1. 3. • Accuracy Required in Work: Accuracy in interpretation and effective communication of a variety of regulations and guidelines is required to ensure the safety and compliance of employees. Accuracy in work products, communication with stakeholders and maintaining records is a critical requirement.
      • Consequence of Error: Failure to prescribe the appropriate safety practice could result in lab accidents, employee exposure to biological or chemical hazards, employee infections, and/or citations or fines from regulatory agencies. Citations can result in the discontinuation of federal funding as well.
      • Instructions Provided to Employees: Communication of proper work practices and policies to employees is accomplished by several means. Various safety training sessions are developed and presented to provide the latest in laboratory health and safety. Routine safety audits provide an opportunity to visit individual laboratories, and relay site-specific information.
      • Guides, Regulations, Policies and References used by Employee: Must have knowledge of all federal, state, and local regulations regarding occupational and environmental safety.  Regulatory agencies include but are not limited to the Occupational Safety and Health Administration (Bloodborne Pathogens, Chemical Hygiene Plan, Respiratory Protection), National Fire Protection Association, Environmental Protection Agency, Centers for Disease Control and Prevention (BMBL, Tuberculosis), National Institutes of Health (Recombinant DNA Guidelines), and Federal Select Agent Regulations. 
      • Supervision: 
        1. Received: Minimal
        2. Given: None
      • Variety and Purpose of Personal Contacts: Must be able to communicate and collaborate with personnel in diverse positions, including housekeepers, students, laboratory technicians, laboratory analysts, principal investigators, physicians, administrators, and regulators.
      • Physical Effort: Must be medically cleared to wear a respirator for OESO spill response team and laboratory entry; Must also be able to physically move and manipulate 55 gallon drums.
      • Work Environment and Conditions: The Specialist works out of an office environment as a base but must be mobile throughout the work environment.  The person in this position must be able to coordinate with available transportation options and have a valid driver’s license to perform site visits.
      • Machine, Tools, Instruments, Equipment and Materials Used: Various types of equipment used for respiratory protection for chemical response or infectious agents, personal computer (MS Office, Access), telephone, fax, copier, and educational materials including slide projectors.
      • Visual Attention, Mental Concentration and Manipulative Skills: Must be able to rapidly assess the workplace for hazards and identify the needs for improvement in safety practices or controls.
      • Safety for Others: The core mission of this position is to ensure the safety of others in the workplace.
      • Dynamics of Work: Will involve work with co-workers and supervisors from diverse backgrounds. Competing priorities will require organizational and prioritization skills to execute tasks in a timely manner to address safety, regulatory and stakeholder concerns.  

Minimum Qualifications

Knowledge, Skills and Abilities

• Excellent written and verbal communication skills are required, with an ability to effectively communicate with a variety of occupational and educational levels.  The Specialist must have extensive knowledge of biological hazards and controls. Additional knowledge in chemical hazards and controls is a plus. The person in this position must possess excellent problem solving skills with the ability to be flexible and respond rapidly to changing situations. This person should also be a self-starter with a can-do attitude, requiring little supervision. A commitment to continuous learning and professional development is required. Working knowledge of Microsoft Office Suite is required to track data, draft communication, prepare and present training, etc. effectively with lab personnel, leadership and other stakeholders.

Education and Experience

• Preferred Minimum Education: Ph.D. in life sciences or related field with specialization in biological hazard identification and mitigation (biosafety, biosecurity, biocontainment, etc.).
• Required Minimum Education: Bachelor’s degree in Microbiology, Virology, Molecular Biology/Genetics, or related science, plus five years of practical experience working in the health and safety field with specialization in biological hazard identification and mitigation (biosafety, biosecurity, biocontainment, etc.).

Experience

• Five years of related experience.

Degrees, Licensure, and/or Certification

• Must have a valid driver’s license.
• Must have completed or be able to complete HAZWOPER First Responder Operations Level Training (29 CFR 1910.120).
• Certified Biological Safety Professional (CBSP) certification strongly preferred but not required.