Job description

Position Summary:
Develops and implements strategic action, quality improvement and risk management plans. Identifies potential weaknesses and provides senior management with an analysis of outcomes.

• Pediatric Surgery - Regenerative Medicine (Cellular Therapy)
• Full Time
• Exempt
• TMC Location

The QI and regulatory activities (RA) of the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory, an 1850 square feet FDA-registered facility located on the 6th floor of the Behavioral and Biomedical Sciences Building, where tissues and organs are processed to produce cells for clinical applications in compliance with current Good Manufacturing Practice (cGMP) of the FDA. This role also coordinates QI at the Judith R. Hoffberger Cellular Therapeutics Laboratory, a 710 square feet facility located on the 6th floor of the Medical School Building which up to now has been used as a preclinical translational laboratory. Thanks to her exceptional work contribution, the Griffin facility continues to be accredited under the new Common Standards for Cellular Therapy by the Foundation for the Accreditation of Cellular Therapy (FACT) yearly, the most prestigious and rigorous authority in the field.

• *Position may include occasional weekend hours and on call response, which is compensated, as well as some flexibility in hours and availability.

POSITION KEY ACCOUNTABILITIES:

1. Conducts periodic review of records to assess and ensure compliance with internal policies and procedures.
2. Meets and collaborates with managers to develop performance improvement plans and monitors ongoing outcomes.
3. Conducts periodic audits of processes and data to ensure compliance and assists in preparation and success of audits from regulatory governing bodies. Includes audits of Personnel and Environment monitoring.
4. Analyzes audit reviews to identify areas needing improvement and detection of risk management issues.
5. Develops, implements and monitors quality improvement and risk management plans.
6. Assist in preparation for lab FACT, CAP, and CLIA accreditation and registration by working closely with accreditation counselors/coordinators to complete required documentation, and to assist in gap analysis by preparing missing documentation as identified by accreditation organization in a timely manner
7. Participates as an active member of the Safety Committee and addresses areas needing improvement
8. Contributes to the systems applications development required to collect necessary data to monitor performance improvement indicators.
9. Analyzes data and creates necessary quality reports to identify performance improvement issues and compares outcomes to similar institutions.
10. Prepares statistical variances and trends in graphs and charts to review with senior management.
11. Conducts educational training for staff regarding Performance Improvement principals and processes.
12. Performs other duties as assigned
PREFERRED CERTIFICATIONS/SKILLS:
Certified Medical Technologist (MT) by the American Society of Clinical Pathologists (ASCP)
Certification from the Association of Clinical Research Professionals (ACRP)
MINIMUM EDUCATION:
Bachelor’s degree or related experience.
MINIMUM EXPERIENCE:
Required:
Five years professional experience in a healthcare or academic setting with one year experience with research laboratory, regulatory compliance or education. May substitute required education with additional years of equivalent experience or applicable degree on one to one basis.
Preferred:
Three years’ experience in clinical processing of cellular products and two years lead/supervisor experience

Job Type: Full-time

Benefits:

• Dental insurance
• Employee assistance program
• Employee discount
• Health insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• Monday to Friday
• Weekend availability

Application Question(s):

• Please specify which Certification of the following you possess:

Certified Medical Technologist (MT) by the American Society of Clinical Pathologists (ASCP)
Certification from the Association of Clinical Research Professionals (ACRP)

• This position includes occasional weekend hours and on call response, as well as some flexibility in hours and availability. Are you interested and available for this responsibility in schedule, which is compensated?

Education:

• Bachelor's (Required)

Experience:

• clinical processing of cellular products: 3 years (Required)
• supervisor: 2 years (Required)

Work Location: One location

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