QC Analyst I/II (Contract)

Our client is a CDMO seeking a Quality Control Analyst I/II (Contract) to help ensure consistent quality of their cell manufacturing process. You will perform laboratory tests on incoming raw materials, in-process samples, and final product samples before distribution. You will carefully and consistently analyze this data to ensure product specifications are met, or perform peer reviews of other analyses. As part of this role, you will also review current GMP documentation related to SOPs, testing methods, and protocols.

Responsibilities:

• Successfully execute and document laboratory procedures and experiments with great attention to detail
• Perform QC testing on raw materials, in-process and final product samples
• Assess data to ensure product specifications are met
• Assist in reviewing data
• Perform technical root-cause investigations for aberrant results and deviations relating to analytical methods
• Responsible for raw materials inspection, sampling and testing in support of clinical and commercial products in compliance with GMP requirements.
• Collaborate closely with Interdepartmental MSAT and Manufacturing groups to support, execute, and/or provide oversight in the execution of method optimization, characterization, troubleshooting, transfer, and qualification
• Perform additional duties as assigned

Qualifications:

• B.S. degree in biology or related field with experience in cell therapy, immunology, cancer biology, or a closely related field, and 0-3 years (QC Analyst I) or +3 years of industry experience (QC Analyst II)
• Experience with relevant technologies with an emphasis on multicolor flow cytometry, MSD, Immunospot, cell culture (e.g., aseptic techniques, cell line expansion), multiplexed immunoassay, NGS, qPCR, and dPCR methods
• Experience with assay development, method qualification, and routine testing in GLP and/or GMP environment
• Experience with contract laboratories and or CDMO is a plus
• Knowledge related to laboratory information management systems (LIMS) and electronic lab notebook record keeping (ELN) is a plus
• Proficient in MS Word, Excel, Project, and PowerPoint
• Experience with gene and cell therapies or the pharmaceutical industry is a plus
• Availability to work extended hours to meet deadlines when necessary
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of the initial job description