QA Representative - Warehouse

Lilly • Durham, NC

1d • $65,250 - $169,400 • Hybrid

About The Position

The Lilly RTP warehouse is a fully automated warehouse system with automated pallet conveyors, pallet exchangers, ASRS (Automated storage and retrieval system), and AGV (Autonomous Guided Vehicle) delivery of materials to the line. The Quality Assurance Representative for the Warehouse and Logistics teams provide daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedures revisions, validations, batch disposition, commissioning, and qualification activities, with a focus on Automated Warehouse operations. This role reports directly to the Sr. Manager- QA Materials and Logistics. The Quality Assurance Representative position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval/General Inspections by various regulatory agencies.

Requirements

• Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study.
• 2+ years previous quality experience supporting device, parenteral/drug substance products/materials, or medical device industry in QA roles.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
• Proficiency with computer systems including Microsoft office products, inventory management systems, and deviation management systems (i.e., SAP, Veeva, Trackwise, etc.)

Nice To Haves

• Proven ability to work independently or as part of a team to troubleshoot and assess root cause.
• Strong attention to detail.
• Demonstrated strong oral, written and interpersonal communication skills.
• Demonstrated decision making and problem-solving skills.
• Previous experience in GMP production environments.
• Demonstrate knowledge and understanding of manufacturing process and Quality Systems.
• Previous experience in warehousing operations.
• Previous experience with ASRS warehousing, Autonomous Guided Vehicles, and integrated systems.
• Previous work with combination products or devices with experience with US/EU regulations and notified bodies.
• CQE, or CQA certification from the American Society for Quality (ASQ)
• Computer Systems Quality (CSQA) experience
• Previous facility or area start up experience.

Responsibilities

• Responsible for adhering to safety rules and maintaining a safe work environment for both self and others by supporting safety corporate and site goals.
• Lead, mentor, and coach operations and support personnel on quality matters.
• Ensure regular presence in warehousing areas, while also supporting device assembly and packaging areas, to monitor GMP programs, and quality systems.
• Active on local cross-functional teams with focus on Warehousing. Logistics, 3rd party logistics and supply chain matters.
• Provide quality support with third-party warehouse locations that maintain RTP materials.
• Ability to assess and triage deviations, supplier or service provider issues that occur within the warehouse, logistics, supply chain or 3rd party logistics areas.
• Work with Lilly support groups and external partners (including 3rd party logistics) to resolve or provide advice on receiving, shipping, storage or production supply issues.
• Participate in self-led inspections and provide support during internal / external regulatory inspections.
• Effectively review and / or redline to ensure quality attributes are met. (i.e, deviations, supplier complaints, procedures, technical studies, validation protocols, change controls, and engineering documents).
• Approve commissioning qualification / validation documents for computer systems and equipment related to the warehousing operations, to ensure compliance with quality standards.
• Participate in Six Sigma Projects focused on continuous improvement and productivity within the quality organization or cross-functional teams.

Benefits

• company bonus
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level