> Markdown version of [/jobs/ext/734700-associate-qa-supplier-quality](https://www.wearedevelopers.com/jobs/ext/734700-associate-qa-supplier-quality). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Associate - QA Supplier Quality - **Company:** Celltrion Branchburg, Llc - **Location:** Branchburg, NJ, United States - **Experience:** Expert - **Salary:** $71,250.0 - $145,000.0 - **Contract:** Permanent contract - **Skills:** Microsoft Word, Microsoft Excel, Data Integrity, Microsoft Office, SAP ERP, Microsoft PowerPoint, Information Technology, Trackwise - **Published:** June 29, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=4d709d6fd599d752 ## About the Role Do you have experience in Vendor compliance audits?, * Bachelor's Degree required in Chemistry, Engineering, Life Sciences, or related discipline. * Minimum 5 years of direct experience conducting and leading external supplier audits. * Experience supporting Health Authority inspections involving supplier oversight. * Strong understanding of applicable regulatory requirements (i.e. 21 CFR Parts 210/211), ICH guidelines, data integrity principles, and risk management concepts. * Microsoft Office (Word, Excel, PowerPoint), SAP experience required. Additional Preferences: * ASQ Certified Quality Auditor or equivalent credential. * Must possess working knowledge of domestic and international GMP regulations and other policies/regulations as applicable. * Must have strong technical writing skills. * Possesses a conceptual understanding of all Quality functions and business areas. * Must have the ability to function in a fast-paced environment and communicate effectively with management and external parties such as suppliers. * Must be able to work in a cross-functional environment. * Experience with TrackWise preferred. ## Description The Supplier Quality Associate works with cross-functional groups while preparing for and executing routine supplier and service provider audits. Maintains annual audit plan/schedule. May lead small to large projects or programs with moderate risk. Manages quality-related matters specific to area of responsibility. Collaborates with cross-functional groups when troubleshooting investigations and resolving problems. Assists with the implementation of change controls and reviews and/or approves GMP documents associated within area of responsibility. Ensures regulatory compliance and procedural consistency within GMP areas particularly supplier quality, material management, and logistics/warehouse operations. Ensures area of responsibility remain inspection ready and assists during regulatory/GMP inspections. Ensures observations associated with the site are adequately addressed and completed on schedule. Requires approximately 20 - 40% travel. Key Objectives/Deliverables: Perform day-to-day activities including (based on area of responsibility): * Plan, coordinate, schedule, and execute supplier and service provider audits. * Develop and manage external audit schedule. * Thoroughly document executed audits including observations, recommended actions, and follow-up activities. Track observation responses to completion and escalated significant issues accordingly. * Evaluate and process observations, trends or deviations to determine root cause(s) and assess quality impact. Recommend CAPA's and ensure CAPAs implemented are effective. * Creates/maintains quality agreements. * Ensures harmonization of raw material specifications across other company sites. * Writes supplier performance evaluations * Evaluate change controls and associated risk assessments. * Ensure sustainable compliance to all regulations related to area of oversight (e.g. 21 CFR Part 11 related to computer systems etc). * Review/approve SOP's, Reports, specifications and Work Orders for compliance to regulatory standards. * Review/approve raw material specification packages and support material management at Branchburg site * Assist in creating quality metrics. Keep Quality Management informed of compliance issues. * Assist with activities associated with technology transfers or product launches to and from Lilly Branchburg facilities. * Attend and serve as a key resource in ad-hoc meetings to provide compliance guidance. * Support Logistics, Manufacturing, Quality Control, Maintenance, Validation and other business units as necessary. * Ensure compliance with applicable company global standards and regulatory guidelines. * May serve as core member on Process Team(s), continuous improvement, and general site support. * Participate in Regulatory and partner inspections as necessary. 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