QA Representative - Warehouse

About the role

The Quality Assurance Representative for the Warehouse and Logistics teams provides 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.

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.
• Absess 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.

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.
• Proficiency with computer systems including Microsoft office products, inventory management systems, and deviation management systems (i.e., SAP, Veeva, Trackwise, etc.).

Qualifications

• 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.