QC Analyst I-BioAssay

About the role

The Basic Summary QC Analyst II position requires a strong focus on detail, organizational skills, and proficiency with laboratory instrumentation.

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 and excellent documentation skills for reviewing test results of other QC analysts.
• Maintains efficient workflow and ensures timely submission of required testing documentation relative to product release dates.
• Study design, data/statistical analysis, and reporting results in both written and oral formats (presentations).
• Enters observations and results into appropriate trending databases for periodic analysis and trending.
• Assists in maintaining proper operation of the QC department (inventory management, logs, documentation, filing, etc.).
• Participates in quality improvement initiatives and investigations as needed.
• Adheres to Standard Operating Procedures (SOPs) and good documentation practices to ensure data integrity and traceability.
• Performs other related duties as assigned.

Qualifications

• Bachelor's degree in 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 techniques 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.

Pay

Pay ranges between $20-$24/hr based on experience.