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Manufacturing Quality Specialist (2nd Shift)

Louisville, KY, us💼 Full-time🗓 2026-08-10 → 2026-09-26

Core

Ensures quality and compliance of oligonucleotide products throughout the manufacturing process, implementing process controls and audits.

Role type

Manufacturing Quality Specialist

Builds

Oligonucleotide products

Domain

Pharmaceutical manufacturing / Life Sciences

Deliverable

production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work

Required skills

Quality audits, Nonconformance management, Root cause analysis, CAPA management, KPI monitoring, QMS support, Process improvement, Equipment validation

Preferred skills

Quality management software proficiency, Risk management tools, Manufacturing equipment familiarity

Responsibilities

Investigate customer complaints and manage product returns, Perform final QC checks on VIP/Special projects, Conduct manufacturing process audits, Lead CAPA initiatives and root cause analysis, Monitor and report manufacturing KPIs, Train production staff on quality standards

Seniority

Mid-level, hands-on IC

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