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Hired by Matrix, Inc · 1 hour ago

Quality Systems Specialist

Exton, PA

Contract

Hybrid

Mid Level

3+ years exp

Hired by Matrix, Inc is a global pharmaceutical company seeking a Quality Systems Specialist. The role involves performing core regional quality systems activities, developing and revising SOPs, and conducting analysis and reporting of quality metrics.

Human ResourcesMarketingStaffing Agency

Growth Opportunities

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 controlCollaborative playerProblem escalationEffective communication

Required

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

Proven performance in earlier role

Works as a collaborative player and effectively seeks/ conveys understanding of diverse viewpoints

Communicates with colleagues across levels as needed and influences for the best outcomes

Presents information(written and verbal) in a clear, well thought out way and tailored to the audience

Escalates issues/problems and seeks support in a timely manner