Quality Assurance Specialist

Community Health Network•Indianapolis, IN

About The Position

Join our community Community Health Network has an excellent opportunity available within our Clinical Research Oncology Team. If you are looking for challenging work and meaningful advancement, then you should consider a career with Community. Where you fit in The primary purpose of the Quality Assurance Specialist (QAS) position is to manage the Cell Therapy Laboratory (CTL) Quality Management Plan for the Stem Cell Transplant and Cellular Therapy Institute (SCTCTI) and to ensure compliance with applicable regulatory agencies. The QAS oversees the creation of Standard Operating Procedures (SOPs), policies, forms and labels; reviews processing records; conducts quality investigations, audits, and risk assessments; investigates and closes out deviations; ensures readiness and compliance with accreditation organizations standards and federal regulations; gathers data on key performance indicators (KPIs) to create continuous quality improvement reports.

Requirements

4 year / Bachelor's Degree (Required) In lieu of the above education requirements, a combination of experience and education will be considered.
2+ years: Two years’ experience with quality assurance and/or regulatory compliance. (Required)
5+ years: Five years of professional experience with direct experience as a lab technician (Required)

Nice To Haves

Direct experience working with cellular therapy products. (Preferred)
ASQ Certification
Certified Professional Healthcare in Quality (CPHQ)

Responsibilities

Manage the Cell Therapy Laboratory (CTL) Quality Management Plan for the Stem Cell Transplant and Cellular Therapy Institute (SCTCTI) and ensure compliance with applicable regulatory agencies.
Oversee the creation of Standard Operating Procedures (SOPs), policies, forms and labels.
Review processing records.
Conduct quality investigations, audits, and risk assessments.
Investigate and close out deviations.
Ensure readiness and compliance with accreditation organizations standards and federal regulations.
Gather data on key performance indicators (KPIs) to create continuous quality improvement reports.
Evaluate quality systems, regulatory compliance, areas of product review and release, change control, documentation review and approval, validation and maintenance of forms utilized by SCTCTI laboratory staff.
Work in tandem with SCTCTI teams to submit individual Investigational New Drug applications (INDs) when necessary to support patient care.
Management of Event Tracking Reports, including tracking, data gathering, review, investigation and close-out. Also, determination of need for Quality Investigation and Corrective Action Preventative Action (CAPA).
Perform internal audits based on key quality indicators, and participate in external audits such as accreditation, external sponsors, or regulatory organizations.
Review patient records after cellular product infusion. Work in tandem with SCTCTI clinical quality director to maintain appropriate FACT standards, as applicable.
Oversight of Validation Plans and Summary Reports, Risk Assessments, and Change Control.
Responsible for Vendor Qualifications and approval of Product Specification Sheets for reagents and supplies.
Assist with laboratory tasks as operational needs arise.