QA Associate – Biologics - Eurofins CDMO Alphora, Inc.
Core
Support quality oversight of GMP activities for biologics manufacturing, including batch review, release, deviations, and environmental monitoring.
Role type
Associate-level Quality Assurance Specialist (Biologics)
Builds
Clinical and commercial biopharmaceuticals (mAbs, ADCs, therapeutic proteins)
Domain
Biopharmaceuticals / Contract Development and Manufacturing (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, environmental monitoring, SOP development, audit support
Preferred skills
Monoclonal antibody (mAb) experience, antibody-drug conjugate (ADC) knowledge, sterile fill/aseptic processing, biochemistry/microbiology background
Technologies
LIMS, ERP, GMP software suites
Responsibilities
Review batch records and release documentation, conduct root cause analysis for deviations, support change control assessments, participate in internal and external audits, develop and review SOPs, manage environmental monitoring programs
Seniority
Junior to Mid-level, hands-on IC