Quality Control Specialist needed!

Overview:

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