Demo

Supplier Quality Specialist

Nitto Denko
Milford, MA Full Time
POSTED ON 3/3/2025
AVAILABLE BEFORE 6/2/2025

About this opportunity :

As a Supplier Quality Specialist you will handle the raw material management and supplier qualification program. The role will coordinate key elements of raw material / supplier qualification, QA release, and Quality system metric tracking to ensure all regulatory and customer expectations are fulfilled.

Key Responsibilities :

  • Own develop and maintain supplier quality management procedures and guidelines.
  • Support supplier audits, assessments and inspections to verify compliance with quality standards and specifications.
  • Deploy quality risk management principles to ensure appropriate risk mitigation and controls exercised.
  • Maintain precise documentation and records related to quality management activities.
  • Prepare and deliver reports on supplier quality performance to management.
  • Analyze data to uncover trends and identify areas for enhancement.
  • Utilize statistical tools to support quality analysis and informed decision-making regarding suppliers.
  • Initiate and facilitate corrective and preventative actions for quality issues or non-conformances.
  • Provide technical guidance and support for laboratory, procurement, engineering and production teams on materials and services selection, evaluation and qualification.
  • Provide and monitor developed Quality KPI's
  • Establish and implement relative quality assurance protocols and procedures.
  • Support routine internal audit and supplier audit processes to verify adherence to quality standards.
  • Maintain a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities.

Required Skills / Abilities :

  • Bachelor of Science degree, with Science and / or Chemistry background.
  • 1-3 years' experience in a regulated / GMP industry required, with experience in Pharmaceuticals or Biotechnology preferred.
  • Understanding of 21 CFR 210, 21 CFR 211, and ICH Q7 regulations.
  • Ability to work in a fast-paced environment consisting of internal and external team members with minimal oversight.
  • Problem-solving skills with the ability to adapt to changing priorities and timelines.
  • Experienced in the use of electronic systems such as SAP, eQMS.
  • Ability to build positive working partnerships with other department teams.
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