Quality and Regulatory Specialist

Health Network Laboratories LLC; United States; Presencial; USD 85.000 - 115.000; Jornada completa

Descripción de la vacante

Health Network Laboratories LLC seeks a Quality & Regulatory Specialist to support the quality management program and regulatory standards within a clinical laboratory environment. You will develop and maintain a QMS, monitor metrics, and coordinate external inspections to ensure accreditation and compliance with CAP, DOH, OSHA, CMS, and TJC.

You will lead document control, CAPA investigations, risk assessments, and training initiatives, fostering a culture of quality, safety, and continuous

Formación

• Bachelor’s degree in a health care-related field; MT/MLS preferred.
• Minimum of 5 years’ experience in laboratory operations.
• Experience overseeing quality/regulatory functions or 2–3 years in accreditation/regulatory/safety standards (CAP, TJC, DOH, FDA, CMS, ISO).
• Certification by a recognized certifying body for quality professionals preferred (ASQ, NAHQ, ISO).
• Strong analytical, problem-solving and cross-department collaboration skills.

Responsabilidades

• Develop, implement, and maintain a comprehensive QMS aligned with accreditation standards (e.g., CLIA, ISO).
• Collaborate with management to develop, implement, and track quality metrics to meet regulatory standards.
• Coordinate external inspections/audits (CAP, DOH, OSHA, CMS, TJC, etc.).
• Maintain document control system and ensure document integrity.
• Identify, document, and investigate non-conforming events; implement CAPA.
• Support risk management and legal for discovery; perform RCA and RA.
• Provide training materials and oversee quality/safety topics.
• Promote culture of quality, safety, and continuous improvement across departments.

Conocimientos

Quality management

Regulatory knowledge

Data analysis

CAP/DOH/CMS experience

Documentation control

Audit coordination

Risk assessment

CAPA

Educación

Bachelor’s degree

MT/MLS degree preferred

Herramientas

LIS

Microsoft Office

Descripción del empleo

Work Schedule:
Monday - Friday 8:00 a - 4:30 O

The Quality & Regulatory Specialist supports quality 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 quality management system (QMS) aligned with relevant accreditation standards (e.g., CLIA, ISO).
• Collaborate with the laboratory management to develop, implement, and track key quality metrics to align with laboratory goals and meet regulatory standards.
• Analyze and identify trends in statistical quality data; collaborate with the laboratory to implement improvement actions; generate reports to communicate outcomes of quality 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 inspection/ survey 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 standards, and addressing any gaps identified during the inspection/ survey process. Collaborate with external inspector(s)/ surveyor(s) to resolve findings and implement corrective and preventive actions as needed.
• Coordinate, plan and conduct internal quality and safety 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.
• Implement and maintain document control system to include policy development and revisions as they pertain to regulatory and accreditation requirements.
• Provide guidance to policy owners and technical subject matter experts regarding document content/formatting/approval workflows to ensure document integrity and quality in accordance with regulatory and accreditation requirements.
• Identify, document, and investigate non-conforming events, patient safety events and client feedback, utilizing event reporting system(s). Ensure timely resolution and implementation of effective corrective action and preventive actions (CAPA). Generate reports to communicate trends and outcomes of quality activities.
• Support the Risk Manager and legal counsel in gathering necessary documents for discovery requests. Conduct Root Cause Analysis (RCA) and Risk Assessments (RA) as needed, while ensuring the confidentiality of patient and client information.
• Assist with quality and safety meeting preparation and participates in meetings as assigned. Represents the quality department on HNL projects. Assists with the preparation of the annual reports as they pertain to Accreditation, Quality & Safety related topics.
• Support the manager in daily operations and provide assistance with tasks as needed.
• Develop training materials/programs as well as policies and procedures pertaining to quality, safety & regulatory requirements and provide training to laboratory staff.
• Promotes internal and external customer satisfaction and a culture of service excellence by meeting the customer’s quality expectations.
• 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, safety matters to ensure the laboratory complies with regulatory requirements, safety protocols, and accreditation standard.

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 quality professionals preferred (ASQ, NAHQ, ISO, etc.).

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