Quality Assurance ISO Specialist

IBEX IT Business Experts (IBEX) is a nationally recognized project management, training, and professional services firm focused on supporting the needs of both Government and commercial sectors. In 2021, and for the fourth year in a row, IBEX was named to the INC 5000 list of fastest-growing companies. Additionally, we are a past recipient of the American Express "On the Rise" Government Contractor of the Year award. In 2021, we were named to the Georgia Fast 40 list of fastest-growing companies in the state. IBEX has grown substantially year over year since its founding in 2012.

At IBEX, our core values are exemplified through our people, products, processes, and daily activities If you have the skills, experience, and alignment with these core values, this position is for you

• Passion for Success
• Intentionally committed to diversity of thought
• Inclusive of all people and perspectives
• Do the right thing, even when no one is watching
• Improving businesses & communities through collaborative solutions

Human Resources Environmental, Social, and Governance Statement

At IBEX, we recognize that our employees are our greatest asset and the foundation of our success. The Human Resources department is at the forefront of embedding Environmental, Social, and Governance (ESG) principles into the heart of our workplace culture, talent management, and operational practices. Our commitment to ESG within HR reflects our dedication to creating a sustainable, equitable, and ethical working environment for all our employees.

Position: Quality Assurance / ISO Specialist (ISO 15189)

Reports To: Director of Program Management

Location: Onsite at Either: Joint Pathology Center, 606 Stephen Sitter Avenue, Silver Spring, Maryland 20910; Joint Pathology Center, 8901 Rockville Pike, Building 17B-Room 4013 Bethesda, MD 20889.

Type: Full-Time, Non-Exempt

Job Summary:

IBEX IT Business Experts, LLC is seeking a Quality Assurance/ ISO Specialist (ISO 15189) who exhibits professional knowledge of the concepts, theories, principles and practices of medical technology sufficient to develop and maintain a quality assurance/control program for the JPC's Molecular Laboratory, Central Cancer Registry and the Depleted Uranium and Embedded Fragment Laboratory, to assess their needs, coordinate laboratory services and implement improvement programs. The ideal candidate will be fully knowledgeable of all certification requirements for ISO 15189 (2) including a broad comprehensive knowledge of laboratory medicine and/or histology to create and implement quality assurance standards. The ideal candidate will make safety and customer service a priority.

Minimum Qualifications:

• Ability to pass Federal Government security/background check
• Must Have the ability to work in the United States
• Hold a Valid Driver's License
• Fully knowledgeable of all certification requirements for ISO 15189
• Knowledge of medical technology, theories, practices, concepts, terminology and established procedural and quality control methodologies as well as broad comprehensive knowledge of laboratory medicine and/or histology to create and implement quality assurance standards.
• Certification through the American Society for Clinical Pathology (ASCP), American Society for Quality (ASQ), and/or certified manager of Quality/Operational Excellence (CMQ/OE).
• Capable of effectively communicating in English, both written and verbal
• Education: Bachelor's degree in medical technology, chemistry, or biology that included or was supplemented by at least: 16 semester hours of biological science of which one course was in microbiology and one course was in immunology
• Experience: 3-5 Years relevant work experience
• Technical Skills: Medical Terminology, MS Office Suite

Preferred Qualifications:

• Knowledge of federal rules and regulations, certifying and accrediting agency requirements, and State and local laws pertaining to clinical laboratories sufficient to provide interpretation to area officials and laboratory personnel and assess impact on laboratory operations and stringent licensing and accrediting agency standards from all applicable state and federal regulatory agencies.
• Mastery of advanced management principles, concepts, regulations, practices, analytical methods and techniques to identify, analyze and recommend solutions to highly complex and often times controversial or sensitive operational problems that are not always susceptible to treatment by standard methods.
• Expert knowledge in applying analytical and evaluative methods and techniques, and the ability to plan, conduct and document a variety of complex analyses and projects, including the development of findings and recommendations, and executing integrated follow-up actions.
• Extensive knowledge of quality assurance/control and risk management administration, theories, principles, methodologies, and techniques. Knowledge of safety practices.
• Comprehensive knowledge and understanding of the organization's mission and functions; goals and objectives; organizational structure; and administrative management guidance.
• Technical expert of accreditation requirements for the American Society for Clinical Pathology (ASCP), the Joint Commission (JC), the College of American Pathologists (CAP) and an understanding of Clinical Laboratory Standards Institutes (CSLI) recommendations and requirements to maintain and monitor accreditation of the JPC.

Responsibilities:

• Ability to lead JPC section teams in their section efforts to be ISO ready.
• Responsible for providing as needed quality control systems, proficiency testing programs, and procedures for preventive maintenance and performance testing of instruments and equipment sufficient to identify and resolve problems and assure compliance with applicable requirements as they relate to ISO certification.
• Technical expert of accreditation requirements for the American Society for Clinical Pathology (ASCP), the Joint Commission (JC), the College of American Pathologists (CAP) and an understanding of Clinical Laboratory Standards Institutes (CSLI) recommendations and requirements to maintain and monitor accreditation of the JPC.
• Ability to provide professional knowledge of the concepts, principles and practices of medical technology sufficient to develop and maintain a quality assurance/control program for the JPC's Molecular Laboratory, Central Cancer Registry and the Depleted Uranium and Embedded Fragment Laboratory, to assess their needs, coordinate laboratory services and implement improvement programs.
• Ability to establish and maintain positive working relationships with internal and external managers, peers, and subordinates.
• Write, interpret, and develop implementing instructions; write policies and procedures; write and present status on special reports; prepare and/or give briefings to higher level management.
• Utilize management, administrative, and coordinative skills to sufficiently and effectively coordinate ISO activities to improve services and utilization of laboratory resources.
• Provide qualitative evaluations of laboratory services, developing/revising guidelines and standards for use by operating personnel, and incorporating new technology in laboratory programs.
• Provide knowledge of recognized reference standards, medico legal responsibilities, accrediting agency requirements, and Federal and State laws and regulations sufficient to ensure that section plans and procedures are consistent with requirements.
• Ability to serve on or lead the efforts of various committees, meeting, workgroups, and process action teams. Assesses laboratory needs and explores sources and methods of obtaining necessary resources i.e. personnel, financial, material etc. Proposes changes in administration, organization, operating procedures for improvements in program efficiency and resource utilization.

Work Environment:

This job requires work to be completed in a laboratory setting using standard office, medical and laboratory equipment. The employee must occasionally lift or move office products and supplies, up to 50 pounds.

Appearance: All personnel shall be attired in business casual clothing for daily work. Attire worn should always ensure employees safety from working conditions (long pants, appropriate shirts and close toe shoes)

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; talk or hear. The employee must portray a professional business attire including closed toe shoes. The employee must always keep the safety of government property secured and undamaged. The employee must occasionally lift or move office products and supplies, up to 50 pounds.

IBEX IT Business Experts, LLC (IBEX) provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, IBEX complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

IBEX expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of IBEX's employees to perform their job duties may result in discipline up to and including discharge.