QC Biology Associate II – Cell Therapy (Temporary)

Artiva Biotherapeutics Inc.; San Diego (CA); On-site; USD 74,000 - 85,000; Full time

Job summary

Artiva Biotherapeutics is seeking a skilled and motivated QC Associate II, QC Biology (Temporary) who will report to the Associate Director, Quality Control. The role focuses on routine cGMP release and stability testing of Artiva's NK cell therapy products, supporting investigations and contributing to QC system improvements.

The contract runs through year-end with possible extension. Candidates should have a BS/BA in biology or related field and a minimum of 2 years of cGMP QC experience in a

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 is required.
• Knowledge and experience in supporting cGMP deviations, OOS, etc.
• Adept at learning critical thinking and technical writing skills.
• Computer skills required to operate Microsoft Word and Excel programs.

Responsibilities

• Assist in ordering supplies, reagents and equipment.
• Write and revise SOPs/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 QC equipment IQ/OQ/PQs.
• Perform routine cGMP release and stability testing of Artiva’s products; including biological tests, biochemistry, chemistry-based tests as needed.
• Support and as needed evaluate QC systems and/or implement system improvements with supervision.
• Support laboratory investigations and write reports for deviations and Out of Specification results.
• Document lab work in a thorough and accurate manner.
• Perform all work according to company policies, SOPs, and cGMP practices.
• 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.
• Assist in analytical qualification and validation, as necessary.
• Support the transfer and optimization of analytical methods 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.

Skills

cGMP QC experience

technical writing

Microsoft Word

Microsoft Excel

Education

Bachelor’s degree in biology or related field

Tools

ELISA

Flow Cytometers

Analytical instruments

Job description

Artiva Biotherapeutics is seeking a skilled and motivated QC Associate II, QC Biology (Temporary) who will report to the Associate Director, Quality Control. The role focuses on routine cGMP release and stability testing of Artiva's NK cell therapy products, supporting investigations and contributing to QC system improvements.

The contract runs through year-end with possible extension. Candidates should have a BS/BA in biology or related field and a minimum of 2 years of cGMP QC experience in a