Quality Assurance Specialist

4 weeks ago

Shanghai, Shanghai, China Cardinal Health Full time

Quality Assurance Specialist

Cardinal Health is seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for assessing processes and practices for regulatory risk and conformance to quality standards.

Responsibilities

  • Conduct thorough audits of assigned suppliers to ensure compliance with regulatory requirements.
  • Develop and implement corrective actions to address audit findings.
  • Collaborate with business leaders to implement improvements and ensure regulatory compliance.
  • Communicate best practices observed to other business units.
  • Prepare for audits by researching materials, standards, policies, and procedures.

Accountabilities

  • Apply knowledge of regulatory requirements, such as MDD, EU-MDR, ISO 13485, and FDA, to ensure compliance.
  • Develop and maintain knowledge of business platforms and processes, such as Veeva Vault, SAP, and Agile PLM.
  • Ability to multi-task and work in a high-paced environment with an awareness of continued impact on compliance and operational performance.
  • Excellent written and verbal communication skills to drive clear alignment of company and department goals.

Qualifications

  • Bachelor's degree in a related field or equivalent work experience.
  • 4+ years of experience in a related field, preferably in quality assurance or regulatory compliance.
  • Current knowledge of GMP auditing and regulation, including FDA 21 CFR 820 and ISO 13485.

What is expected of you and others at this level

  • Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects.
  • May contribute to the development of policies and procedures.
  • Works on complex projects of large scope.

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