Regulatory Specialist, Lab

It's more than a career, it's a calling.

WI-St. Agnes Hospital

Worker Type:

Regular

Job Summary:

Under general direction, is responsible for ensuring adherence to federal and state regulations related to quality and personnel qualifications. Performs audits, investigates non-compliance, and provides guidance to cross functional teams to address any regulatory issues or risk. Manages documentation, auditing practices, regulatory training, and fosters a culture of continuous improvement within the laboratory.

Job Responsibilities and Requirements:

PRIMARY RESPONSIBILITIES

• Assesses adherence to relevant Joint Commission, CAP, CLIA, CMS and FDA regulations, standards, and internal policies to ensure a safe and compliant laboratory environment.
• Maintains and updates regulatory documentation, processes, and procedures to align with evolving guidelines and industry best practices.
• Leads comprehensive on-site surveys and audits to evaluate compliance levels, identifying areas for improvement as needed.
• May manage FACT accreditation, Donor Manufacturing Audits and National Marrow Donor Program responsibilities where applicable.
• Investigates and resolves complaints and non-compliance events, utilizing root cause analysis frameworks to prevent recurrence.
• Develops and delivers training programs for laboratory personnel on compliance and safety standards, enhancing their understanding and capability in maintaining regulatory requirements.
• Prepares clear and comprehensive reports delineating findings, deficiencies, and recommendations for corrective actions based on audit results and investigations.
• Gathers and analyzes data related to compliance performance metrics, communicating findings to key stakeholders.
• Stays informed of changes in regulations and industry standards, ensuring documentation and training materials are kept up-to-date and laboratory is inspection ready at all times.
• Utilizes performance improvement methodologies (e.g., A3 thinking, PDCA, value stream mapping) to drive quality management system enhancements and ongoing process improvement.
• Works effectively within a multidisciplinary team, facilitating communication between various departments, vendors, and regulatory bodies to ensure organizational compliance.
• Performs other duties as assigned.

EDUCATION

• Bachelor's degree in Science, Medical Laboratory Science, Biology or Chemistry or equivalent years of experience and education

EXPERIENCE

• Two years' experience in a laboratory setting

PHYSICAL REQUIREMENTS

• Frequent lifting/carrying and pushing/pulling objects weighing 0-25 lbs.
• Frequent sitting, standing, walking, reaching and repetitive foot/leg and hand/arm movements.
• Frequent use of vision and depth perception for distances near (20 inches or less) and far (20 feet or more) and to identify and distinguish colors.
• Frequent use of hearing and speech to share information through oral communication. Ability to hear alarms, malfunctioning machinery, etc.
• Frequent keyboard use/data entry.
• Occasional bending, stooping, kneeling, squatting, twisting and gripping.
• Occasional lifting/carrying and pushing/pulling objects weighing 25-50 lbs.
• Rare climbing.

REQUIRED PROFESSIONAL LICENSE AND/OR CERTIFICATIONS

State of Work Location: Illinois, Missouri, Oklahoma, Wisconsin

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• Specialist in Cytometry (SCYM) (International Included) - American Society for Clinical Pathology (ASCP)
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• Specialist in Microbiology (SM) (International Included) - American Society for Clinical Pathology (ASCP)
• Or
• Specialist in Molecular Biology (SMB) (International Included) - American Society for Clinical Pathology (ASCP)

Work Shift:

Day Shift (United States of America)

Employee

Department:

8050000197 ADMINISTRATIVE

Scheduled Weekly Hours:

40

Benefits:

SSM Health values our exceptional employees by offering a comprehensive benefits package to fit their needs.

• Paid Parental Leave: we offer eligible team members one week of paid parental leave for newborns or newly adopted children (pro-rated based on FTE). 

• Flexible Payment Options: our voluntary benefit offered through DailyPay offers eligible hourly team members instant access to their earned, unpaid base pay (fees may apply) before payday.

• Upfront Tuition Coverage: we provide upfront tuition coverage through FlexPath Funded for eligible team members. 

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SSM Health is an equal opportunity employer. SSM Health does not discriminate on the basis of race, color, religion, national origin, age, disability, sex, sexual orientation, gender identity, pregnancy, veteran status, or any other characteristic protected by applicable law. Click here to learn more.