Senior Specialist, QC Analytical, Cell Therapy

Role Summary

Senior Specialist, QC Analytical, Cell Therapy – responsible for clinical and commercial lot file review, testing of incoming raw materials, sampling, labeling tracking and shipping of samples.

Responsibilities

• Perform review of clinical and commercial QC Lot Files
• Perform review of Raw Material Lot Files
• Provide oversight and accountability of the QC Lot File process for the following
• Commercial Lot Files
• Clinical Lot Files
• Raw Material Lot Files
• Review GMP documentation and perform data verification.
• Support document revision, project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
• May train others on general job duties.
• Perform other tasks as assigned.

Qualifications

• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Apply scientific principles to analytical testing and the proper use of laboratory equipment.
• Ability to communicate effectively with peers and management regarding task completion, roadblocks, and needs.
• Attention to detail and demonstrated organizational skills.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.

Education

• Bachelor's degree preferred in science. Associate degree with equivalent combination of education and work experience may be considered.
• 4+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
• Demonstrated experience with basic laboratory techniques and basic laboratory safety practices.
• Prior experience in lot file review and/or management is preferred.