Artiva Biotherapeutics

Associate II/III, Quality Control Environmental Monitoring

Artiva Biotherapeutics$77K — $93K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Microbiology or related scientific discipline.
  • 4-6 years of cGMP QC experience in cell therapy, biotech, or pharmaceutical industry.
  • Expertise in Environmental Monitoring (EM) programs and regulatory expectations.
  • Strong background in aseptic techniques and cGMP gowning practices.
  • Proven ability to lead investigations and implement Corrective Actions and Preventive Actions (CAPA).
  • Experience with authoring and reviewing SOPs, protocols, and technical documents.
  • Excellent problem-solving and technical writing skills with minimal supervision.

Responsibilities

  • Oversee and perform environmental monitoring tests for the cGMP EM program.
  • Conduct gowning qualifications for personnel accessing the cGMP facility.
  • Coordinate environmental monitoring efforts with Manufacturing operations.
  • Act as a subject matter expert for EM systems and electronic databases.
  • Perform growth promotion testing to support EM media release.
  • Document, review, and trend EM data, identifying adverse trends for management.
  • Lead investigations for EM excursions, conducting root cause analysis and CAPA implementation.

Benefits

  • Beautiful facility
  • Collaborative and innovative work environment
  • Medical, Dental, and Vision insurance
  • Group Life Insurance and Long-Term Disability coverage
  • 401(k) Retirement Plan
  • Employee Assistance Program (EAP)
  • Flexible Spending Account (FSA)
  • Paid Time Off (PTO) and company-paid holidays
  • Recognition program for employee rewards through Bonus.ly
Full Job Description
Job Summary: 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. Duties/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. Qualifications: - 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). In addition to a great culture, we offer: - A beautiful facility - An entrepreneurial, highly collaborative, and innovative environment - Comprehensive benefits, including: - Medical, Dental, and Vision - Group Life Insurance - Long Term Disability (LTD) - 401(k) Retirement Plan - Employee Assistance Program (EAP) - Flexible Spending Account (FSA) - Paid Time Off (PTO) - Company paid holidays, including the year-end holiday week - Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. If all this speaks to you, come join us on our journey! Base Salary: $77,000 - $93,000. Exact compensation may vary based on level, skills and experience.

About Artiva Biotherapeutics

Artiva Biotherapeutics is a clinical-stage biotechnology company developing a pipeline of novel, precisely targeted immuno-oncology therapies. The company's proprietary technology platform leverages a deep understanding of the biology of immune cells and their interactions with cancer cells to develop therapies that can selectively activate or suppress immune responses to cancer. Artiva's lead product candidate, AB-101, is a first-in-class, off-the-shelf, allogeneic cell therapy that targets solid tumors by activating natural killer (NK) cells. The company was founded in 2019 and is headquartered in South San Francisco, California.
Learn more about Artiva Biotherapeutics
Size
20 employees
Industry
Net Income
-$16
Founded
2019
NASDAQ

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