Job title: QA Associate, Cellular Therapy
#Associate #Cellular #Therapy
Job description: Description
UPMC Hillman Cancer Center is internationally recognized for its leadership in the prevention, detection, diagnosis, and treatment of cancer and is the region’s only comprehensive cancer center designated by the National Cancer Institute.
As the preeminent institution in western Pennsylvania for the delivery of cancer care, the performance of basic, translational, and clinical research, and the education of the next generation of cancer researchers and physicians, UPMC Hillman Cancer Center is exceptionally well positioned to contribute to the global effort to reduce the burden of cancer.
UPMC Hillman Cancer Center is currently hiring a QA Associate for our Cellular Therapy team. This will be a Monday through Friday position located at Shadyside Hospital.
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. Act as the liaison between nursing, the quality departments and regulatory departments of the hospitals to deliver safe and complaint cellular therapy products. The successful applicant will interact with clinical trial sponsors, cellular manufacturing, research scientists, project management, and senior members of the UPMC Hillman Cancer Center administration.
The Quality Assurance team facilitates the Quality Management Program for multiple cellular therapy laboratories – each, specializing in their own processes supporting unique protocols. You will be able to be introduced to and be an integral part of supporting novel therapies.
Are you a team player that is looking for a rewarding career in a fast-paced environment? Apply today!
- 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, 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.
- 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).
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
COVID-19 Vaccination Information
Individuals hired into this role must comply with UPMC’s COVID vaccination requirements upon beginning employment with UPMC. Refer to the COVID-19 Vaccination Information section at the top of this page to learn more.
More than just competitive pay and benefits, package cares for you in all areas of life — because we believe that you’re at your best when receiving the support you need: professional, personal, financial, and more.
At UPMC, we’re driven by shared values that guide our work and keep us accountable to one another. Our Values of Quality & Safety, Dignity & Respect, Caring & Listening, Responsibility & Integrity, Excellence & Innovation play a vital role in creating a cohesive, positive experience for our employees, patients, health plan members, and community. Ready to join us? Apply today.
Current UPMC employees must apply in
Expected salary: $24.78 – 42.84 per hour
Location: Pittsburgh, PA
Job date: Sat, 09 Jul 2022 00:58:10 GMT