Quality Associate II
Core
Ensuring all clinical trial work is performed in compliance with regulatory requirements, cGMP, and SOPs by inspecting products and maintaining quality documentation.
Role type
Quality Assurance Associate (Manufacturing)
Builds
Clinical trial products for pharma, biotech, and consumer health customers
Domain
Pharmaceutical manufacturing / Contract Development and Manufacturing Organization (CDMO)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Component inspection, bulk drug inspection, certificate of analysis creation, batch record review, cleaning procedure execution, specification interpretation, JD Edwards (IMS) proficiency
Preferred skills
Packaging experience, mathematical reasoning, scientific reasoning
Technologies
JD Edwards (IMS)
Responsibilities
Create Certificate of Analysis, Inspect bulk drug and packaged finished product, Perform Component Inspection, Execute Cleaning Procedures, Review Pre-Batch and Post-Batch records, Manage Component Release Packets and Reclass Approvals
Seniority
Entry-level to Mid-level, individual contributor
