Associate - QA Supplier Quality
Role details
Job location
Tech stack
Job 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.
Requirements
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.
Benefits & conditions
Pulled from the full job description
- Health insurance
- Retirement plan
- Paid time off
- Vision insurance
- Dental insurance
- Life insurance
- Disability insurance, 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.