Associate - QA Supplier Auditing (Must have auditing experience)

Job Description

Job Description

Celltrion is a leading biopharmaceutical company that specializes in research, development and manufacturing of innovative therapeutics. We are committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. We have been at the forefront of biotherapeutic development uncovering new ways of targeting the drivers of disease by creating next-generation biologics and small molecule products. Celltrion Branchburg, LLC is a subsidiary of Celltrion USA, established in 2025 following Celltrion USA’s acquisition of Eli Lilly’s drug substance (DS) manufacturing facility located in Branchburg. By linking robust local manufacturing capabilities with an existing direct sales network, we aim to generate greater synergies across our operations. Looking ahead, we also anticipate expanding into the global contract manufacturing organization (CMO) sector.

Position Brand 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. Ensure timely follow up to any inspection findings.

Basic Requirements:

• 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.

This role is exempt and the anticipated compensation for this role is $71,250 - $145,000.

This is a banded role, and candidates will be placed within the range based on experience, skills, internal equity, and market considerations.

Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability benefits. This role requires up to 20-40% travel, on-call availability, and may involve shift work. Hybrid work flexibility may be available based on business needs; relocation assistance is not provided.

Celltrion Branchburg, LLC is proud to be Equal Opportunity Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.