Aizon
Life Science
QualityProgramAssociate
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Quality Program Associate at Aizon. Skills: Quality program management, Computer system validation, GMP/GxP compliance. Support creation of quality plans. Maintain quality plans”
Industry & Context.
What They're Looking For.
Must Have
Bachelor's degree in relevant field, 0-2 years experience, Familiarity with GMP/GxP concepts, Solid written and verbal English, Attention to detail, Organization and documentation discipline, Comfortable with software tools, Willing to comply with regulations
Nice to Have
Exposure to Computer System Validation, Knowledge of data integrity principles, Experience with project management tools, Understanding of pharmaceutical manufacturing, Spanish and/or additional languages, Familiarity with SaaS/cloud solutions, Knowledge of Atlasian ecosystem
What You'll Do.
Support creation of quality plans
Maintain quality plans
Execute quality plans
Assist with computer system validation
Draft validation deliverables
Execute validation deliverables
Help coordinate GMP projects
Track project deliverables
Track project timelines
Provide support on consulting engagements
Gather customer requirements
Translate requirements into documentation
Maintain documentation and records
Assist with change control documentation
Assist with deviation documentation
Assist with CAPA documentation
Perform internal audits
Prepare validation evidence
Organize quality evidence
Support external audits
Collaborate with product teams
Collaborate with engineering teams
Collaborate with delivery teams
Contribute to continuous improvement
Improve quality program templates
Improve best practices
How You'll Work.
Team & Collaboration
Internal teams; Customer teams; Product teams; Engineering teams; Delivery teams; Technical stakeholders; Non-technical stakeholders
Communication Scope
Written documentation; Verbal communication
Process & Methodology
Project support, Tracking deliverables, Tracking timelines, Tracking action items
Full Job Description
## Description Who we are Aizon is a software-as-a-service provider that transforms manufacturing operations in life science industries using advanced analytics and artificial intelligence. Following our recent Series C round of growth funding, we are looking for ambitious new team members motivated to directly impact our future growth and success as we launch what we consider “Aizon 3.0”. Aizon is helping pharma manufacturers and CDMOs make better decisions in GMP operations. What makes us different from other manufacturing platforms? - We help operations leaders and engineers avoid endless cycles of chasing data in disparate and heavy-handed systems and rapidly understand how to run their manufacturing processes better. - We’re solving multiple problems in GMP operations that cost manufacturers millions yearly while accelerating their digital maturity journey. One of our unique capabilities is the ability to operationalize the use of predictive AI models in real-time without a big data science staff. - We’re backed by both industry and software investor firms like NewVale Capital, Atlantic Bridge, Danaher, Honeywell, CrossLink, and UnCork, with solid industry and technology expertise. Our mission is to improve global health by optimizing how medicines are manufactured so that pharma and biotech companies can provide patients worldwide with the right medicine at the right time and price. Join us if you are motivated to directly impact our company's success and growth path forward and, more importantly, by positively contributing to the life science industry and deserving patients worldwide. ## Key Responsibilities Support the creation, maintenance, and execution of quality plans for customer implementation projects, ensuring alignment with GMP/GxP requirements. Assist in computer system validation (CSV/CSA) activities for Aizon solutions, helping draft and execute validation deliverables (validation plans, requirements and specifications, IQ/OQ/PQ test protocols, t
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