Cell Therapy Integrated Service and QA Specialist-Vector Production Lab
MetroHealth, Cleveland, OH, United States
Location:
METROHEALTH MEDICAL CENTER
Biweekly Hours:
80.00
Shift:
8-4:30
The MetroHealth System is redefining health care by going beyond medical treatment to improve the foundations of community health and well-being: affordable housing, a cleaner environment, economic opportunity and access to fresh food, convenient transportation, legal help and other services. The system strives to become as good at preventing disease as it is at treating it. Founded in 1837, Cuyahoga County's safety-net health system operates four hospitals, four emergency departments and more than 20 health centers.
Summary
Responsible for processing clinical and clinical research cellular therapy products for infusion into patients. The Cell Therapy Lab is responsible for processing and storage of cellular products for use in compliance with Good Clinical Practices (GCP), Food and Drug Administration (FDA), Current Good Manufacturing Practice (cGMP), Current Good Tissue Practices (cGTP), and Foundation for the Accreditation of Cellular Therapy (FACT) regulations. The laboratory supports the Stem Cell Transplant program of MetroHealth and somatic cell therapy clinical trials at MetroHealth, regional partners, and nationally. Additionally, the position provides quality assurance expertise and oversight to ensure compliance of complex programmatic activities with regulatory and accreditation agency laws and guidelines. Upholds the mission, vision, values, and customer service standards of The MetroHealth System.
Qualifications
Required:
Minimum of a BA/BS in biology, Medical Technology or other healthcare-related field or any equivalent combination of education, training, and experience in addition to the experience stated below.
3 years laboratory experience in a healthcare-related field.
3 years QA or quality compliance experience in a regulatory environment.
Working knowledge of FDA, cGMP, cGTP, and GMP.
Certification in Human Subjects Protection and HIPAA training (within 3 months of hire).
Familiarity with basic laboratory equipment and experience in aseptic technique, including cell culture.
Excellent verbal and written communication skills, including the ability to effectively interface with physicians, nurses and laboratory personnel.
Proficient in the use of the Microsoft Office Suite of products, including Word, Excel, and Access.
Preferred:
Advanced degree.
5+ years laboratory and QA experience.
Expert knowledge of FDA, cGMP, cGTP, and GMP.
American Society of Clinical Pathology (ASCP) certification.
Physical Demands
May sit, stand, stoop, bend, and ambulate intermittently during the day.
May need to sit or stand for extended periods.
See in the normal visual range with or without correction.
Hear in the normal audio range with or without correction.
Finger dexterity to operate office equipment required.
Ability to communicate in face-to-face, phone, email, and other communications.
Ability to see computer monitor and departmental documents.
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METROHEALTH MEDICAL CENTER
Biweekly Hours:
80.00
Shift:
8-4:30
The MetroHealth System is redefining health care by going beyond medical treatment to improve the foundations of community health and well-being: affordable housing, a cleaner environment, economic opportunity and access to fresh food, convenient transportation, legal help and other services. The system strives to become as good at preventing disease as it is at treating it. Founded in 1837, Cuyahoga County's safety-net health system operates four hospitals, four emergency departments and more than 20 health centers.
Summary
Responsible for processing clinical and clinical research cellular therapy products for infusion into patients. The Cell Therapy Lab is responsible for processing and storage of cellular products for use in compliance with Good Clinical Practices (GCP), Food and Drug Administration (FDA), Current Good Manufacturing Practice (cGMP), Current Good Tissue Practices (cGTP), and Foundation for the Accreditation of Cellular Therapy (FACT) regulations. The laboratory supports the Stem Cell Transplant program of MetroHealth and somatic cell therapy clinical trials at MetroHealth, regional partners, and nationally. Additionally, the position provides quality assurance expertise and oversight to ensure compliance of complex programmatic activities with regulatory and accreditation agency laws and guidelines. Upholds the mission, vision, values, and customer service standards of The MetroHealth System.
Qualifications
Required:
Minimum of a BA/BS in biology, Medical Technology or other healthcare-related field or any equivalent combination of education, training, and experience in addition to the experience stated below.
3 years laboratory experience in a healthcare-related field.
3 years QA or quality compliance experience in a regulatory environment.
Working knowledge of FDA, cGMP, cGTP, and GMP.
Certification in Human Subjects Protection and HIPAA training (within 3 months of hire).
Familiarity with basic laboratory equipment and experience in aseptic technique, including cell culture.
Excellent verbal and written communication skills, including the ability to effectively interface with physicians, nurses and laboratory personnel.
Proficient in the use of the Microsoft Office Suite of products, including Word, Excel, and Access.
Preferred:
Advanced degree.
5+ years laboratory and QA experience.
Expert knowledge of FDA, cGMP, cGTP, and GMP.
American Society of Clinical Pathology (ASCP) certification.
Physical Demands
May sit, stand, stoop, bend, and ambulate intermittently during the day.
May need to sit or stand for extended periods.
See in the normal visual range with or without correction.
Hear in the normal audio range with or without correction.
Finger dexterity to operate office equipment required.
Ability to communicate in face-to-face, phone, email, and other communications.
Ability to see computer monitor and departmental documents.
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