Associate I/II, Quality Control Environmental Monitoring (Contract to Hire)

Artiva Biotherapeutics•San Diego, CA

13d•Onsite

About The Position

Artiva Biotherapeutics seeks a skilled and motivated QC Associate I or II for Environmental Monitoring (Contract to hire), to support the Quality Control environmental monitoring program and report to the Manager, Quality Control. This role is responsible for monitoring and assessing the cGMP manufacturing environment to detect, quantify, and help identify potential contaminants that could impact product quality. Key responsibilities include performing viable and non-viable air monitoring, surface bioburden sampling, gowning qualifications, and growth promotion testing of media used in biopharmaceutical manufacturing.

Requirements

Bachelor’s (BA/BS) in Microbiology or related scientific discipline.
At least 1-3 years of cGMP QC experience in cell therapy/biotech/pharmaceutical industry.
Experience with aseptic techniques and adherence to cGMP gowning and hygiene practices.
Excellent critical thinking, problem solving, and technical writing skills.
Excellent interpersonal and communication skills to facilitate and follow.
Proficiency with electronic systems and Microsoft Office applications (Word, Excel, etc).

Nice To Haves

Experience in EM programs, including data trending, excursion management and regulatory expectations is preferred.

Responsibilities

Perform testing for Artiva’s cGMP EM program, including non-viable particulate monitoring, viable air, and surface monitoring utilizing proper aseptic techniques.
Perform Gowning Qualifications for personnel requiring access to the cGMP facility.
Coordinate EM support with manufacturing operations.
Utilize an electronic database system for EM sampling.
Perform growth promotion testing to support the release of EM media.
Accurately document, review and trend EM data within GMP electronic database; identify adverse trends and escalate findings to management.
Support EM excursions and out-of-trend events, including root cause analysis, impact assessment and CAPA.
Assist in revising SOP’s, test forms, logbooks, and technical documents to support the EM program.
Maintain records and databases in accordance with procedures.
Perform routine maintenance, cleaning and upkeep of laboratory equipment to ensure operational readiness.
Maintain adequate inventory of test supplies and order laboratory materials.
Troubleshoot assay and instrument problems.
Maintain records and databases in accordance with procedures.
Adhere to all safety requirements, performing work in compliance with OSHA regulations and company safety policies.