QA Compliance Specialist: Vendor Management & Readiness

BeOne Medicines

Pennington (NJ)

On-site

USD 55,000 - 74,000

Full time

3 days ago
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Benefits offered by this job

Medical
Dental
Vision
401K

Job summary

BeOne Medicines is actively seeking a Quality Assurance professional to support vendor qualification, qualification renewals, and change controls at the Hopewell site. This role focuses on maintaining inspection readiness and compliance across supplier relationships.

You will collaborate with Internal and External Supply Quality, Legal, and vendors to ensure approvals, change management, and regulatory documentation are handled efficiently, supporting high-stakes manufacturing operations.

Qualifications

  • Bachelor’s degree required and at least 2 years of related experience.
  • Experience in regulated pharmaceutical or manufacturing environments.
  • Knowledge of vendor/material qualification and change management processes.

Responsibilities

  • Lead qualification of new vendors and materials for the Hopewell site.
  • Maintain and audit the Approved Vendor List.
  • Ensure BSE/TSE evaluations and regulatory documentation.
  • Support FDA inspection readiness activities and supplier audits.

Skills

Quality Assurance
Vendor Qualification
Change Control
Inspection Readiness
Regulatory Compliance

Education

Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, Quality Assurance, Regulatory Affairs

Job description

BeOne Medicines is actively seeking a Quality Assurance professional to support vendor qualification, qualification renewals, and change controls at the Hopewell site. This role focuses on maintaining inspection readiness and compliance across supplier relationships.

You will collaborate with Internal and External Supply Quality, Legal, and vendors to ensure approvals, change management, and regulatory documentation are handled efficiently, supporting high-stakes manufacturing operations.

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