Vendor Quality Specialist

Meet Life Sciences; Pennington (NJ); On-site; USD 85,000 - 120,000; Full time

Job summary

Meet Life Sciences in the United States (New Jersey) seeks a Vendor Quality Specialist to support vendor and material qualification activities within a regulated pharmaceutical manufacturing environment. This role will oversee supplier lifecycle management, change controls, quality agreements, compliance documentation, and inspection readiness.

You will lead vendor qualification, manage reassessments, monitor supplier changes, and collaborate with Quality, Legal, and vendors on QA agreements and

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, Quality, Regulatory Affairs with 2+ years of relevant experience.
• Experience in Quality Assurance, Quality Compliance, Supplier/Vendor Quality in a regulated pharma/manufacturing environment.
• Knowledge of vendor/material qualification, supplier change management, quality agreements, and change controls.
• Familiarity with regulatory inspections and inspection readiness.
• Ability to manage multiple priorities in a fast-paced, regulated environment.

Responsibilities

• Lead vendor and material qualification and maintain the site Approved Vendor List.
• Manage vendor reassessments, documentation, schedules, and follow-up activities.
• Monitor supplier changes and initiate or support change controls and required site documentation.
• Ensure BSE/TSE evaluations and other compliance requirements are completed for manufacturing materials.
• Partner with Quality, Supply Quality, Legal, and vendors on Quality Assurance Agreements and vendor audits.
• Support shared vendor qualification and reassessment activities across sites.
• Provide support for FDA inspections, audits, and inspection readiness, including backroom activities.
• Identify and implement improvements to vendor management and qualification processes.

Skills

Vendor qualification

Material qualification

Quality Assurance

Supplier quality

Change controls

Quality agreements

Regulatory inspections

Inspection readiness

Documentation management

Cross-functional collaboration

Education

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

Job description

Seeking a Vendor Quality Specialist to support vendor and material qualification activities within a regulated pharmaceutical manufacturing environment. This role will oversee supplier lifecycle management, change controls, quality agreements, compliance documentation, and inspection readiness.

Responsibilities

• Lead vendor and material qualification and maintain the site Approved Vendor List.
• Manage vendor reassessments, documentation, schedules, and follow-up activities.
• Monitor supplier changes and initiate or support change controls and required site documentation.
• Ensure BSE/TSE evaluations and other compliance requirements are completed for manufacturing materials.
• Partner with Quality, Supply Quality, Legal, and vendors on Quality Assurance Agreements and vendor audits.
• Support shared vendor qualification and reassessment activities across sites.
• Provide support for FDA inspections, audits, and inspection readiness, including backroom activities.
• Identify and implement improvements to vendor management and qualification processes.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, Quality, Regulatory Affairs, or related field, with 2+ years of relevant experience.
• Experience in Quality Assurance, Quality Compliance, Supplier/Vendor Quality, or a related regulated pharmaceutical or manufacturing environment.
• Knowledge of vendor/material qualification, supplier change management, quality agreements, and change controls.
• Familiarity with regulatory inspections and inspection readiness.
• Ability to manage multiple priorities in a fast-paced, regulated environment.