Quality and Regulatory Specialist

HNL Lab Medicine•Allentown, PA

1d•Onsite

About The Position

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.

Requirements

Bachelor’s degree required from an accredited program in a health care-related field or equivalent scientific field.
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).
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.
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.
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
Ability to use Microsoft office product, and various other computer software products including the Laboratory Information System.

Nice To Haves

MT/MLS degree preferred.
Certification by recognized certifying agency for quality professionals preferred (ASQ, NAHQ, ISO, etc.).

Responsibilities

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, and safety matters to ensure the laboratory complies with regulatory requirements, safety protocols, and accreditation standard.