Associate II/III, Quality Control Environmental Monitoring

Artiva Biotherapeutics•San Diego, CA

1d•$77,000 - $93,000•Onsite

About The Position

Artiva Biotherapeutics seeks a skilled and motivated QC Associate II or III for Environmental Monitoring (EM), 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 4-6 years of cGMP QC experience in a cell therapy/biotech/pharmaceutical industry.
Expertise in EM programs, including data trending, excursion management and regulatory expectations.
Strong experience with aseptic techniques and adherence to cGMP gowning and hygiene practices.
Ability to lead investigations, perform root cause analysis and implement CAPA’s.
Experience authoring and reviewing SOPs, protocols and technical reports.
Excellent critical thinking, problem solving, and technical writing skills with minimal supervision.
Excellent interpersonal and communication skills, with the ability to influence cross-functional teams.
Proficiency with electronic systems and Microsoft Office applications (Word, Excel, etc).

Responsibilities

Perform and independently oversee environmental monitoring testing for Artiva’s cGMP EM program, including non-viable particulate monitoring, viable air, and surface monitoring utilizing proper aseptic techniques.
Perform and oversee gowning qualifications for personnel requiring access to the cGMP facility.
Coordinate EM support with Manufacturing operations.
Serve as a subject matter expert resource for EM systems, including electronic databases.
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.
Lead investigations for EM excursions and out-of-trend events, including root cause analysis, impact assessment and CAPA.
Author, revise and approve SOP’s, forms, logbooks and technical documents to support the EM program.
Independently author and review technical protocols, validation documents and summary reports.
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.