QC BioAssay Analyst I or II

BASIC SUMMARY: QC Analyst II requires the utmost attention to detail, very strong organizational skills, computer proficiency, and a basic understanding of laboratory instrumentation. In addition, effective communication skills and the ability to function in a fast-paced, highly technical environment are essential for success.

ESSENTIAL DUTIES AND RESPONSIBILITIES: • Strong background and experience with cell-based immunological in vitro methods (e.g. MLR, cytotoxicity, HLA-restriction, CTLp, cell proliferation, etc.) and instrumentation.• An understanding of cGMP/GLP regulations as well as excellent documentation skills in order to complete paperwork dealing in all aspects of Quality Control Reviews test results of other QC analysts for accuracy and precision and maintains efficient workflow of an required testing documentation ensuring timely submission relative to product release dates• Study design, data/statistical analysis, reporting results in both written and oral format (presentation)• Enters observations and results into the appropriate trending databases for periodic analysis and trending• Previous experience working with aseptic techniques and culturing of mammalian cells and familiarity with cell culturing basics• Assists the QC Team with maintaining proper overall operation of department (inventories, logs, documentation, filing, etc.)• Assists with implementation of quality improvement initiatives for QC laboratory operations Participates in laboratory, OOS, CAPA, or other investigations, as required• Adheres to Standard Operating Procedures (SOPs) and good documentation practices to ensure data integrity and traceability• Perform all other related duties as assigned.

QUALIFICATIONS: • Bachelors degree in the biological sciences or related field preferred• Minimum 1-2 years of applicable experience in laboratory, biotech, cell therapy, or related industry or a combination of 1-2 years of education and related work experience required.• Previous experience working with aseptic technique and culturing of mammalian cells• Familiarity with cGMP as defined in 21CFR210 and 211.• Detail-oriented with strong written and verbal communication skills• Experience in cell-based assays and molecular biology-based assays• Ability to work independently and as part of a team