Job Title: QA Compliance Specialist

Work Location: Mercer County, New Jersey

Summary:

The QA Compliance Specialist is responsible for overseeing vendor and material qualification processes, ensuring compliance with regulatory standards, and supporting inspection readiness activities within a regulated manufacturing environment.

Responsibilities:

• Oversee the qualification of new vendors and materials, ensuring adherence to established procedures and regulatory requirements.
• Maintain and update the Approved Vendor List, ensuring accuracy and compliance with site standards.
• Track and complete periodic vendor reassessments to support ongoing compliance and supplier lifecycle management.
• Manage documentation, schedules, and follow-ups related to vendor and material qualification, including change controls and supplier notifications.
• Ensure all materials used in manufacturing have required BSE/TSE evaluations and initiate site documentation for supplier changes as needed.
• Collaborate with internal and external quality teams, legal, and vendors to generate and route Quality Assurance Agreements and support vendor audits.
• Provide support for inspection readiness, including preparation for regulatory inspections and participation in audit activities.
• Continuously review and improve vendor management and qualification processes to enhance compliance and support day-to-day business needs.

Qualifications:

• Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, Quality Assurance, Regulatory Affairs, or a related discipline, with at least two years of relevant experience.
• Equivalent combination of education and relevant experience in a regulated pharmaceutical, biotechnology, or manufacturing environment may be considered.
• Experience in Quality Assurance, Quality Compliance, Vendor Quality, Supplier Quality, or a related regulated environment.
• Knowledge of vendor and material qualification, supplier change management, quality agreements, and change control processes.
• Familiarity with inspection readiness activities and regulatory inspection support.
• Strong skills in cross-functional collaboration, documentation, organization, and communication.
• Ability to manage multiple priorities and support business needs in a fast-paced, regulated environment.

Published Category: Quality & Validation