Quality Assurance Associate
Core
Support the site's Quality Management System by ensuring batch documentation compliance, coordinating customer complaint investigations, and driving continuous improvement initiatives.
Role type
Quality Assurance Associate (Manufacturing)
Builds
Pharmaceutical/medical device products in a sterile manufacturing environment
Domain
Healthcare manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance knowledge, batch documentation review, customer complaint investigation, root cause analysis, trend analysis, CAPA management, regulatory standards understanding, quality management software proficiency
Preferred skills
Sterile manufacturing experience, analytical skills, ability to manage multiple tasks
Responsibilities
Review batch documents for compliance prior to market release, investigate and close customer complaints, perform trend analysis on complaints and waste, conduct root cause analysis for deviations and non-conformances, manage NCRs and MPIs, provide inputs for management reviews
Seniority
Individual Contributor
