Senior Quality Assurance Specialist

2 weeks ago


New York, United States X4 Life Sciences Full time

A long term partner of X4 Life Sciences is looking to add a Senior Quality Assurance to it's rapidly growing team.


Our client are a global leader in medical biotechnologies, specializing in cellular therapies, manufactured in the USA, and are currently operating out of Brooklyn, NY.


Position Overview:

As a Senior Quality Assurance Specialist, you will play a critical role in ensuring the quality and regulatory compliance of QMS medical devices. This position involves a range of responsibilities, including managing deviations, conducting internal audits, addressing nonconformities, implementing corrective and preventive actions (CAPAs), overseeing critical suppliers, and handling document revisions via Veeva Vault. Additionally, you will be involved in change control processes and contribute to the preparation of mock batch recall reports.


Key Responsibilities:

  • Investigate and manage deviations from established procedures, ensuring timely resolution and documentation.
  • Audits: Plan, conduct, and report on internal audits to ensure adherence to regulatory requirements and internal quality standards.
  • Identify, assess, and address nonconformities, implementing corrective actions to prevent recurrence.
  • Drive the CAPA process, including root cause analysis, corrective action planning, and effectiveness verification.
  • Suppliers: Collaborate with cross-functional teams to manage critical suppliers and ensure their compliance with quality standards.
  • Revisions (Veeva Vault): Oversee document control activities, including revisions, approvals, and maintenance of documentation within the Veeva Vault system.
  • Controls: Evaluate and manage change controls, ensuring that changes are implemented in compliance with regulatory requirements.
  • Batch Recall Reports: Contribute to the preparation and execution of mock batch recall reports to assess and improve the effectiveness of our recall procedures.


Qualifications:

  • Degree in a related field (e.g., Life Sciences, Engineering, Biochemistry, Pharmacist) + a minimum of 5 years of experience.
  • Preferred.
  • Experience in quality assurance within the medical device industry.
  • Knowledge of regulatory requirements (FDA, ISO 13485) and quality management systems with Veeva Vault or similar document control systems communication and interpersonal skills. with a focus on continuous improvement.


Interviews are commencing this week, so please apply within.



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