Supplier Quality Associate

Key Responsibilities: Support Supplier Quality activities associated with the build-out and operational readiness of a new biologics manufacturing facility. Assist with the qualification, evaluation, approval, and ongoing oversight of external suppliers, vendors, and service providers. Review supplier documentation, quality records, and supporting materials to ensure alignment with internal quality procedures and applicable regulatory requirements. Support supplier audits, assessments, and follow-up activities, including tracking findings and corrective actions. Assist with supplier-related quality investigations, nonconformances, deviations, and corrective and preventive actions (CAPAs). Help maintain supplier quality documentation, approved supplier records, and other controlled quality systems documentation. Partner with cross-functional teams to assess supplier performance, address quality concerns, and support timely resolution of issues. Track supplier quality metrics, open action items, and deliverables to support site readiness and ongoing compliance. Contribute to continuous improvement initiatives focused on supplier quality, compliance, and operational effectiveness.

Qualifications: Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or a related discipline preferred. Approximately 1-5 years of relevant industry experience in Supplier Quality, Quality Assurance, Quality Engineering, or a related quality function. Experience in the pharmaceutical, biotechnology, biologics, or other regulated manufacturing industry strongly preferred. Familiarity with supplier qualification, supplier audits, quality documentation, nonconformances, deviations, or CAPA processes. Understanding of Good Manufacturing Practices (GMP) and applicable quality and regulatory requirements. Strong organizational skills, attention to detail, and the ability to manage documentation and follow-up activities. Effective written and verbal communication skills, with the ability to collaborate across cross-functional teams and external partners. Proficiency with Microsoft Office applications and the ability to learn quality management systems and related tools.

Additional Information: This is a hands-on opportunity to support the development and operational readiness of a new biologics manufacturing site. The initial contract is expected to run through 2027, with potential for extension or conversion based on business needs and performance. Candidates with pharmaceutical or biologics experience and a strong foundation in quality systems are encouraged to apply. This job opens for applications on 10/22/2026. Applications for this job will be accepted for at least 30 days from the posting date. LI-KP1 #LI-ONSITE