Quality Control Lab Technician, Cell and Gene Therapy

Title: Quality Control Lab Technician, Cell and Gene Therapy

Location: Onsite, Pittsburgh, PA 15219
Type: 6-month contract to hire 
Hours: 8AM-5PM
Start: November 

Overview:
Join a Cell Therapy manufacturing department in which you will play a critical role, performing advanced laboratory testing and processing. Also, involved with the manufacture of cellular therapy products for patient treatment by utilizing cutting-edge techniques and advanced instrumentation

Responsibilities

• Author SOPs and qualify, validate processes and platforms for process development, process control, and product release.
• Perform specialized Quality Control tests related to CGT product development and clinical studies. This includes testing for identity, purity, composition, integrity, safety, activity, stability, viability, and potency assays
• Collect background information for testing/experiments/production; initiate paperwork, perform test set-up, work area, and equipment.
• Calculate and analyze assay/test results and quality control information. Investigate abnormal results in accordance with established protocols.
• Implement all quality controls to ensure assay and process validity; adhere to departmental safety standards in responsibly handling, processing, and testing specimens and materials.
• Follow cGMP (current good manufacturing practices) guidelines in the production of cellular products.
• Maintain detailed laboratory documentation of all assays and processes performed as per GDP (good documentation practices) guidelines.
• Use reagents and supplies in a cost-effective manner; monitor and maintain an appropriate supply inventory.
• Adhere to established laboratory and hospital policies in areas of procedures, protocols, methods, quality control, quality assurance, safety, compliance, and personnel policies.
• Interact with all laboratory customers courteously and professionally.
• Perform all responsibilities according to internal policies, SOPs, and the philosophy of the UPMC Health System. Maintain in-depth knowledge of techniques, principles, and instruments, as well as their interrelationships.
• Participate in the execution of assigned projects.
• Participate in laboratory competency assessments and proficiencies as required.
  

Requirements

• Bachelor’s degree in biology or a related field with laboratory experience in molecular cell biology, cell culture, and basic analytical techniques.
• Be self-driven, sincere, thorough, and have an eye for details
  

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.



System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.



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Ref: #558-Scientific