Oklahoma City, OK, 73163, USA
61 days ago
Regulatory Specialist, Lab
**It's more than a career, it's a calling.** OK-SSM Health St. Anthony Hospital - Oklahoma City **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 + Blood Bank Technologist (BB) (International Included) - American Society for Clinical Pathology (ASCP) + Or + Chemistry Technologist (C) (International Included) - American Society for Clinical Pathology (ASCP) + Or + Cytogenetics Technologist (CG) (International Included) - American Society for Clinical Pathology (ASCP) + Or + Hematology Technologist (H) (International Included) - American Society for Clinical Pathology (ASCP) + Or + Medical Laboratory Scientist (MLS) (International Included) - American Society for Clinical Pathology (ASCP) + Or + Medical Lab Scientist (MLS) - American Medical Technologists (AMT) + Or + Medical Technologist (MT) - American Association for Bioanalysts (AAB) + Or + Medical Technologist (MT) - American Medical Technologists (AMT) + Or + Medical Technologist (MT) - American Society for Clinical Pathology (ASCP) + Or + Microbiology Technologist (M) (International Included) - American Society for Clinical Pathology (ASCP) + Or + Molecular Biology Technologist (MB) (International Included) - American Society for Clinical Pathology (ASCP) + Or + Specialist in Blood Banking (SBB) (International Included) - American Society for Clinical Pathology (ASCP) + Or + Specialist in Chemistry (SC) (International Included) - American Society for Clinical Pathology (ASCP) + Or + Specialist in Cytology (SCT) (International Included) - American Society for Clinical Pathology (ASCP) + Or + Specialist in Cytometry (SCYM) (International Included) - American Society for Clinical Pathology (ASCP) + Or + 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) **Job Type:** Employee **Department:** 3408000040 Lab Admin **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. Explore All Benefits (https://jobs.ssmhealth.com/us/en/benefits) _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. (https://www.ssmhealth.com/privacy-notices-terms-of-use/non-discrimination?\_ga=2.205881493.704955970.1667719643-240470506.1667719643)_
Confirm your E-mail: Send Email