QA Associate – Biologics - Eurofins CDMO Alphora, Inc.
Core
Ensure compliance with cGMP for the production of safe and efficacious clinical and commercial biologics pharmaceuticals, including monoclonal antibodies and antibody-drug conjugates.
Role type
QA Associate (Biologics)
Builds
Biotechnology-derived pharmaceuticals (mAbs, ADCs) via sterile fill-finish and bulk processing
Domain
Pharmaceutical manufacturing (Biologics/CDMO)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, batch record review, deviation investigation, change control management, environmental monitoring, SOP development, audit coordination, data review/approval
Preferred skills
Biologic pharmaceutical experience (mAbs, ADCs), sterile fill/aseptic processing, Biochemistry/Microbiology background
Technologies
GMP analytical/QC laboratory systems, sterile fill-finish equipment
Responsibilities
Provide quality oversight for GMP activities across facilities, bulk processing, and fill-finish; Review and release batch records and analytical data; Support deviation investigations and root cause analysis; Assist in preparation of customer and regulatory audits; Contribute to QMS development and SOP writing.
Seniority
Mid-level, hands-on IC
