Job Description

Work Schedule:

Monday-Friday, 8:00 a-4:30p

The Laboratory Safety & Regulatory Specialist supports safety and regulatory functions in accordance with HNL’s quality management program and applicable policies. This role provides support and subject matter expertise relating to applicable OSHA, DOH, CMS, CAP, and other accrediting bodies & regulatory standards relative to the laboratory environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to, the following:

• Develop, implement, and maintain a comprehensive safety program to align with HNL’s quality management system (QMS) and relevant regulatory and accreditation standards (e.g., OSHA, DOT, CLIA, ISO).
• Collaborate with laboratory management to develop, implement, and track key safety metrics to align with laboratory goals and meet regulatory standards.
• Analyze and identify trends in statistical safety data; collaborate with the laboratory to implement improvement actions; generate reports to communicate the outcomes of safety activities.
• Serve as the primary point of contact for external regulatory agencies, ensuring timely communication and resolution of regulatory inquiries or compliance issues. Manage certifications and licenses, maintaining a positive relationship with external authorities to ensure laboratory accreditation and regulatory standing are upheld.
• Coordinate and support external inspections/surveys from regulatory and accreditation bodies (e.g., CAP, DOH, OSHA, CMS, TJC, etc.). Ensure that the laboratory is fully prepared for these audits by ensuring compliance with relevant safety and quality standards and addressing any gaps identified during the inspection/survey process. Collaborate with external inspectors/surveyors to resolve findings and implement corrective and preventive actions as needed.
• Coordinate, plan, and conduct internal safety and quality inspections of all laboratory departments and Acute Care Laboratories as assigned. Record and analyze findings, identify trends, and collaborate with the laboratory to implement effective corrective and preventive actions.
• Serve as the Chemical Hygiene Officer. Implement and maintain the chemical inventory system, including the electronic safety data system (SDS), and develop and revise policies as they pertain to regulatory and accreditation requirements. Manage hazardous and chemical waste and coordinate waste removal with related vendors.
• Develop and implement the biosafety program; create and maintain comprehensive biosafety, biocontainment, and biosecurity management programs to ensure compliance with regulatory requirements. Perform risk assessment and make recommendations as per safety standards and guidelines. Provide guidance to laboratory management for implementation of recommendations.
• Serve as the safety officer and liaison between employees and management. Act as the chair of the safety committee, leading safety committee meetings (preparing agendas, presentations, minutes, etc.). Ensure that safety issues are discussed, actions are taken to address concerns, and that the committee functions properly with clear goals, defined roles, and responsibilities.
• Identify, document, and investigate safety events, including employee safety events, patient safety events, and client feedback, utilizing event reporting system(s). Collaborate with employee health, infection prevention, and employees as required. Ensure timely resolution and implementation of effective corrective action and preventive actions (CAPA). Generate reports to communicate trends and outcomes of quality activities.
• Represent the safety department on HNL projects that involve the construction or addition of laboratory instruments to any of the HNL Lab Medicine Laboratories.
• Support the Risk Manager in daily operations and provide assistance with tasks as needed.
• Develop training materials/programs as well as policies and procedures pertaining to safety and regulatory requirements and provide training to laboratory staff to ensure a safe laboratory environment.
• Promote safety awareness by fostering awareness through campaigns, communications, and visible safety reminders. Engage and motivate other members of the safety committee, encouraging active participation in safety activities and initiatives.
• Cultivate a culture of quality, safety, and continuous improvement by encouraging data-driven decision-making. Guide team members in applying the PDSA cycle to routine tasks, helping them understand how to use data and continuous improvement methodologies to enhance their work processes.
• Foster strong working relationships with laboratory staff and clients through effective interprofessional communication and collaboration. Provide expert guidance on technical, quality, and safety matters to ensure the laboratory complies with regulatory requirements, safety protocols, and accreditation standards.

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, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience:

Bachelor’s degree required from an accredited program in a health care-related field or equivalent scientific field. MT/MLS degree preferred. Minimum of 5 years’ experience working in laboratory operations preferred. Experience overseeing quality/regulatory functions or 2-3 years of experience working in an environment in accordance with accreditation/regulatory/safety standards (e.g., CAP, TJC, DOH, AABB, FDA, CMS, ISO).

Language Ability:

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to collaborate effectively across departments.

Math Ability:

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to compute average, median, and mean and to draw and interpret charts and graphs.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to manage and resolve conflicts effectively between departments and minimizing disruptions to laboratory operations. Strong problem-solving skills with the ability to make informed, data-driven decisions and resolve issues that impact laboratory performance, quality, and safety.

Computer Skills:

Ability to use Microsoft office product, and various other computer software products including the Laboratory Information System.

Certificates and Licenses

Certification by recognized certifying agency for safety professionals preferred (CHSP), and or to obtain within 2 years of employment.

HNL Lab Medicine is an equal opportunity employer. In accordance with, and where applicable, in addition to federal, state and local employment regulations, Lehigh Valley Health Network will provide employment opportunities to all persons without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or other such protected classes as may be defined by law. All personnel actions and programs will adhere to this policy. Personnel actions and programs include, but are not limited to recruitment, selection, hiring, transfers, promotions, terminations, compensation, benefits, educational programs and/or social activities.

Address:

794 Roble Rd

Primary Location:

HNL- Roble

Position Type:

Onsite

Department:

1046-00036 Quality