Associate I - Quality Assurance, On the Floor (3rd Shift)
Core
Execute on-floor quality assurance programs to ensure regulatory compliance and product quality in biopharmaceutical manufacturing.
Role type
Associate I Quality Assurance Specialist (On the Floor)
Builds
Controlled drug products for patients with cancer, autoimmune, fibrotic, blood disorders, HIV, diabetes, heart/lung diseases, and Alzheimer's.
Domain
Biopharmaceutical manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (specifically: batch records, labels, final product containers, controlled production documents)
Required skills
Regulatory compliance knowledge, batch record review, document control, manufacturing walkthroughs, quality issue escalation, material disposition, data log review
Preferred skills
None stated
Technologies
None stated
Responsibilities
Execute QA on the Floor program, Conduct manufacturing walkthroughs, Issue controlled production documents, Review batch records and test data, Release solutions and materials, Inspect final product containers, Escalate quality/regulatory issues, Maintain controlled records
Seniority
Entry-level (0+ years with Bachelor's, 1+ with Associate's, 4+ with High School)
