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Katalyst CRO

Supplier Quality Engineer

Katalyst CRO, Slab City, New York, United States

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Supplier Quality Engineer

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Supplier Quality Engineer

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Katalyst CRO

Functional Engineering Roles include:

Design Assurance, Operations Quality, Software Engineering, Supplier Assurance, Product Analysis, Metrology, Microbiologist, Chemist.

Responsibilities

Identify and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements.

Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.

Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Assure the development and execution of streamlined business systems that effectively identify and resolve quality issues.

Improve supplier quality performance for assigned suppliers via Part Quality Plan (PQP) implementation. Communicate, clarify and facilitate supplier Part Quality Plan (PQP) submissions, as well as conduct PQP review and approval for purchased products.

Approve supplier selection through robust qualification processes, including supplier audits.

Assure supplier compliance with Quality Management System (QMS) and regulatory requirements.

Assure Corrective and Preventive Action (CAPA) plans are developed and executed at assigned suppliers in compliance with the CAPA process.

Requirements

Bachelor's degree - 3-5 years of experience.

Bachelor's Degree in an engineering or technical discipline or a non-technical degree with 7 years of experience in manufacturing, engineering or quality assurance.

Minimum 5 years' experience in manufacturing, engineering design, quality assurance or regulatory assurance.

Effective problem-solving, root cause analytical skills to lead and influence others to drive change.

Seniority level

Associate

Employment type

Contract

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing

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