Specialist, QC Analytical, Cell Therapy

Role Summary

Specialist, QC Analytical, Cell Therapy. Responsible for supporting QC testing for in-process, final product, and stability samples, including data review/verification. May assist with method transfer, documentation, deviations, investigations, and continuous improvement efforts.

Responsibilities

• Perform routine testing of in-process, final product, and stability samples.
• Perform testing for method transfer/validation/verification.
• Perform data verification, data review and review of GMP documentation for general methods.
• May perform document revision, project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts.
• Train analysts 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.
• Knowledge of LIMS, ELN and laboratory data analysis systems preferred.
• Problem-solving ability/mentality, technically adept and logical.
• Ability to communicate effectively with peers, department management and cross-functional peers.
• Experience with writing technical documents preferred.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.

Education

• Bachelor's degree or equivalent required, preferably in science. Netherlands Bachelor's degree / HLO in (bioanalytical) science preferred. MLO level with equivalent combination of work experience may be considered.
• 2+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
• Demonstrated experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique).