Quality Specialist I
Core
Ensure quality compliance across pharmaceutical manufacturing operations, including API manufacturing, testing, batch disposition, and distribution of bulk drug substance.
Role type
Entry-level Quality Specialist (GMP)
Builds
Bulk drug substance products for global customers
Domain
Pharmaceutical manufacturing / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing oversight)
Required skills
GMP regulations knowledge, quality investigations, root cause analysis, documentation review, batch record analysis, CAPA management, change control, regulatory compliance monitoring
Preferred skills
ISO auditor certification, Six Sigma, chemistry/biology/engineering background
Technologies
TrackWise, Documentum, EDMS, Microsoft Office
Responsibilities
Review and approve GMP documentation and batch records; investigate quality events and perform root cause analysis; monitor business process performance measures; assist in writing and revising site SOPs; support training programs for quality processes; participate in client and regulatory audits; troubleshoot quality issues across raw materials to final products.
Seniority
Entry-level (0-3 years experience with degree or 3-5 years without)
