Associate II, Quality Control Biology

Duties/Responsibilities

• Aid in ordering supplies, reagents, and equipment.
• Write and revise Standard Operating Procedures (SOPs) and Test Methods that support Artiva’s cell therapy products.
• Operate and test ELISA, Flow Cytometers, automated cell counters, and other analytical instruments and equipment, as needed.
• Support activities for Quality Control (QC) equipment IQ/OQ/PQs.
• Perform routine cGMP release and stability testing of Artiva’s products, including biological tests, biochemistry, and chemistry-based tests as needed.
• Support and evaluate QC systems, and contribute to their continuous improvement with supervision.
• Contribute to laboratory investigations and write reports for deviations and Out of Specification (OOS) results.
• Document lab work in a thorough and accurate manner.
• Assist in planning for GMP release testing, including testing schedules, reviewing biology data, and investigating OOS and OOT results.
• Write technical QC protocols and reports as needed.
• Support analytical qualification and validation, as necessary.
• Assist in method transfers and optimizations from Analytical Development (or contract laboratories).
• Develop an in-depth understanding of NK products, testing, and safety.
• Maintain records and databases in accordance with procedures.
• Support other special QC projects as needed.

Qualifications

• Bachelor’s degree (BS/BA) or relevant scientific field, preferably in biology or related field.
• Minimum 2 years of cGMP QC experience in a cell therapy/biotech/pharmaceutical setting.
• Knowledge and experience in supporting cGMP deviations, OOS, etc.
• Basic knowledge of method transfers, qualifications, and validations; current industry practices; and some experience with guidance interpretation and application.
• Adept at learning critical thinking and technical writing skills.
• Computer skills required to operate Microsoft Word and Excel programs.

Pay

Base Salary: $79,000 - $91,000. Exact compensation may vary based on level, skills and experience.