Associate – QA Supplier Quality

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.
  • Create/maintain quality agreements.
  • Ensure harmonization of raw material specifications across other company sites.
  • 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.
  • Aid 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.
• Experience with TrackWise preferred.

Pay

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.

Benefits

• Paid time off (holidays, vacation, and additional leave)
• Medical, dental, and vision insurance
• Life insurance
• A company-matched retirement savings plan
• Wellness programs
• Short- and long-term disability benefits

Schedule

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.