The Quality Control Specialist I - Sample Management ensures the time-sensitive distribution of quality control samples supporting QC-related activities. They are responsible for sample inventory management and internal and external sample distribution, including storage and shipping under appropriate conditions, for all the iCTC cell therapy assets. This position works across different shifts. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to ensure the manufacturing process is completed.
Essential Functions and Responsibilities:
Inventory management of Quality Control raw material, in-process, and final product samples, including inventory tracking and reconciliation
Ensures timely sample distribution supporting Quality Control activities, including internal distribution and external shipping
Ensures proper storage of sample inventory and proper shipping conditions, as needed
Manage external vendors concerning inventory management, including sample receipt and documentation
Support internal/external audits as needed
Maintain a current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure the function complies with applicable requirements
Packaging of samples using temperature-controlled dewars, cold packs, and dry ice
Support ramp-up of Quality Control and other activities in a newly built facility
Work in a cleanroom with biohazards, human blood components, and chemicals
Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations
Required Education, Skills, and Knowledge:
Associate degree or 3+ years of relevant GMP experience
Experience with inventory and/or logistics in the pharmaceutical industry
Detail-oriented with strong mathematical skills
Excellent written and verbal communication skills
Strong collaboration, time management, and organizational skills are required
Proven ability to effectively collaborate with a wide range of stakeholders
Excellent judgment and creative problem-solving skills
Ability to work in a fast-paced and dynamic environment
Hands-on laboratory experience with sample handling, inventory, and cryo-shipping