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MD Anderson Cancer Center Quality Assurance Specialist - GMP Laboratory in Houston, Texas

The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report's 2019 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.

The primary purpose of the Quality Assurance Specialist (QAS) position is to manage the department of Stem Cell Transplantation and Cellular Therapy (SCTCT) Cell Therapy Laboratory (CTL) Quality Management Plan and to ensure compliance with the regulatory burden of clinical Investigational New Product (IND) trials. The QAS oversee the creation of SOP, policies, forms and labels; review product manufacturing records; conduct quality investigations, audits, and risk assessments; investigate and close-out deviations; ensure readiness and compliance with accreditation organizations standards and federal regulations; and gathers data on key performance indicators to create continuous quality improvement reports.

Additionally, this position consults and collaborates with clinical investigators at UTMDACC and external sponsors involved in FDA-approved trials. The QAS writes the Chemistry Manufacturing and Control (CMC) section of IND submissions for regulatory approval, participates in the creation of responses to regulatory agency inquiries, manages the submission of revisions/updates to the approved trials and submits annual reports on all current SCTCT/CTL protocols.

KEY FUNCTIONS

Regulatory Compliance

a. Evaluate quality systems, regulatory compliance, and areas of product review and release, change control, documentation review and approval, as well as validation and maintain forms utilized by SCTCT laboratory staff.

b. Prepare CMC section of IND for regulatory submission and annual reports submission to FDA. Primary contact with Clinical Trial Principle Investigators.

c. Responsible for clinical trial final product release.

Quality Assurance

a. Management of Event Tracking Reports, including tracking, data gathering, review, investigation and close-out. Also, determination of need for Quality Investigation and CAPA.

b. Perform internal audits based on key quality indicators, and participates in external audits such as accreditation, external sponsors or regulatory organizations

c. Review patient records after cellular product infusion.

Product Management

a. Oversight of Validation Plans and Summary Reports, Risk Assessments and Change Control.

b. Responsible for Vendor Qualifications and approval of Product Specification Sheets for reagents and supplies.

Other duties as assigned.

EDUCATION

Required: Bachelor's degree in Healthcare, Nursing or a related healthcare field.

EXPERIENCE

Required: Three years of professional experience in a healthcare or academic setting with one year experience with research protocols, regulatory compliance or education. May substitute required education with additional years of equivalent experience or applicable degree on a one to one basis.

Preferred: Five years of professional experience in a healthcare or academic setting with one year experience with research protocols, regulatory compliance or education.

CERTIFICATION

Required: None

Preferred: Certification from the Association of Clinical Research Professionals (ACRP)

It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html

Additional Information

  • Requisition ID: 145307

  • Employment Status: Full-Time

  • Employee Status: Regular

  • FLSA: exempt and not eligible for overtime pay

  • Work Week: Days

  • Fund Type: Hard

  • Pivotal Position: Yes

  • Minimum Salary: US Dollar (USD) 68,800

  • Midpoint Salary: US Dollar (USD) 86,000

  • Maximum Salary : US Dollar (USD) 103,200

  • Science Jobs: No

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