Quality Assurance Compliance Specialist

ClinLab Solutions Group; New Jersey; On-site; USD 75,000 - 110,000; Full time

Job summary

ClinLab Solutions Group in New Jersey is seeking a QA Compliance Specialist to oversee vendor and material qualification processes, ensure regulatory compliance, and support inspection readiness within a regulated manufacturing environment.

You will manage vendor qualification, update AVLs, coordinate change controls and supplier notifications, and collaborate with internal teams and vendors to support audits and regulatory inspections.

Qualifications

• Bachelor’s degree or equivalent in a life sciences or related field with regulatory exposure.
• Experience in a regulated pharmaceutical, biotech, or manufacturing environment.
• Knowledge of vendor/material qualification and change control processes.
• Familiar with inspection readiness activities and regulatory support.
• Strong cross-functional collaboration, documentation, organization and communication.

Responsibilities

• Oversee the qualification of new vendors and materials, ensuring adherence to 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 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.

Skills

Cross-functional collaboration

Documentation

Organization

Communication

Change control

Vendor qualification

Supplier quality

Inspection readiness

Regulatory support

Quality Assurance

Education

Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, Quality Assurance, Regulatory Affairs, or a related discipline

Equivalent combination of education and relevant experience in a regulated pharmaceutical, biotechnology, or manufacturing environment may be considered

Job description

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.