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Hillman Cancer Center has an exciting opportunity to join our Cell Therapy Team!

UPMC Hillman Cancer Center is hiring a full-time QA Associate, Cellular Therapy to support quality assurance for our stem cell labs located at the Hillman Cancer Pavilion and the Riviera building at the Pittsburgh Technology Center. During training, there will be minimal travel from the Hillman Cancer Pavilion. Once training is completed, travel to the other sites will be required and work-from-home flexibility will be available. This is a Monday-Friday daylight position, working between the hours of 8 am-5 pm, with flexibility on start time. No holidays or weekends are required!

The QA Associate will coordinate the quality management, safety, and regulatory activities for the Cellular Processing Facility and Adult and Pediatric Hematopoietic Stem Cell Laboratories. In this role, you will act as the liaison between nursing, the quality departments, and the regulatory departments of the hospitals to deliver safe and compliant cellular therapy products. The QA Associate will interact with clinical trial sponsors, cellular manufacturing, research scientists, project management, and senior members of the UPMC Hillman Cancer Center administration team.

Responsibilities:

+ Collaborate with Project Sponsors and Laboratory Directors to scope requested process development, quality assurance, quality control, and manufacturing activities

+ Create, revise, and maintain policies relating to personnel requirements, quality assurance, quality control, proficiency testing, and lab safety. Distribute to all system-wide laboratories to use or modify for use. Continue to update and revise as needed when federal, state, and accrediting agencies change the standards and regulations.

+ Maintain laboratory Drug Master Files that will be submitted to the FDA. Assist to create and maintain the Laboratory Disaster Plan. Monitor annual laboratory safety inspections. Monitor hazardous and biological waste disposal.

+ Participates as appropriate on various committees related to safety and regulatory compliance as requested and needed.

+ Research regulatory requirements, prepare and submit reports, and assist with quality initiatives. Investigate manufacturing occurrences and deviations. Develop and implement Corrective Action and Preventative action (CAPA). Support change management within the laboratories.

+ Schedule and organize internal audits and accreditation activities; maintain records of all activities on file for reference. Develop internal audit plans and reports. Develop mock audits for preparation of external audits from accreditation bodies or industry-sponsored organizations.

+ Assist in the development of validation plans for cellular processing and equipment.

+ Foster a culture of strong GMP compliance and data integrity. Be innovative when developing and improving quality management systems.

+ BS degree in a biological science or related background from an accredited college/university with at least 3 years of developing or supporting laboratory quality management systems

+ OR MS degree in a biological science or related background from an accredited college/university with at least 1 years of developing or supporting laboratory quality management systems.

+ Prefer prior experience and knowledge of accreditation processes and regulations pertaining to the College of American Pathologists (CAP), Clinical Laboratory Improvement Amendments (CLIA) and Foundation Accreditation of Cellular Therapies (FACT).

+ Prefer prior experience and knowledge of current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP).

+ Previous experience in cell therapy is highly preferred.

Licensure, Certifications, and Clearances:

+ American Society of Quality (ASQ) or Society of Quality Assurance (SQA) certification or membership is recommended.

+ Act 34

UPMC is an Equal Opportunity Employer/Disability/Veteran