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Regulatory Specialist, Lab
- SSM Health (Oklahoma City, OK)
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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)_
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