Associate II, Quality Control Biology (Temporary)

Artiva Biotherapeutics•San Diego, CA

About The Position

Artiva Biotherapeutics is seeking a skilled and motivated QC Associate II, QC Biology (Temporary) who will be reporting to the Associate Director, Quality Control. This individual will perform routine cGMP release and stability testing of Artiva's NK cell therapy products, support laboratory investigations, and contribute to continuous improvement of QC systems. The contract will be through the end of the year with possible extension beyond that.

Requirements

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.
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.

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.