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Joulé · 14 hours ago

Quality Systems Specialist

Exton, PA

Contract

Hybrid

Mid Level

3+ years exp

Joulé is a global Pharma company looking to hire an experienced quality professional to join their growing team. The role involves performing core regional quality systems activities, developing and improving SOPs, and conducting analysis of quality metrics.

Responsibilities

Perform core regional quality systems activities as assigned (e.g., revising procedures; assisting in inspection readiness) following defined procedures

Develop, improve, and revise regional quality system SOPs

Conduct ongoing analysis and reporting of key quality and risk metrics and required actions

Monitor and identify gaps within quality systems area and escalate for appropriate action

Support project management for programs/ projects within quality systems area, and communicate with cross-functional teams within site/ area to drive quality outcomes

Qualification

CGMP complianceQuality systems experienceSOP writingDocument controlAuditing experienceRegulatory inspectionsMetrics monitoringTraining operationsProblem resolution

Required

Bachelor's degree, preferably in chemistry, biochemistry, or equivalent technical discipline

3+ years of experience relevant to role (e.g. auditing and regulatory inspections; learning management systems/ training operations; document control processes; electronic quality systems)

Experience in compliance with cGMPs and relevant health authority and Eisai regional guidelines

Experience in execution of quality processes within own quality systems area (e.g., SOP and protocol writing, metrics monitoring), and assisting in resolution of issues