Scientist - Quality Assurance

Eli Lilly and Company • Research Triangle Park, NC

1d • Onsite

About The Position

The Scientist - Quality Assurance position for the Device Assembly and Packaging team 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. This position is essential for maintaining GMP compliance and providing support during preparation for General Inspections by various regulatory agencies.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field
• Minimum 2 years of experience working effectively with a cross-functional group in a GMP facility
• Demonstrate strong oral and written communication and interpersonal skills.
• Demonstrated decision making and problem-solving skills.
• Strong attention to detail

Nice To Haves

• 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)
• CSQA experience
• Demonstrated knowledge and understanding of manufacturing process and Quality Systems.
• Proficiency with computer systems including Microsoft office products, SAP, Veeva Quality Docs, etc.

Responsibilities

• Responsible for adhering to safety rules and maintaining a safe work environment by supporting HSE corporate and site goals.
• Lead, mentor, and coach operations and support personnel on quality matters.
• Ensure regular presence in device assembly and packaging areas to monitor GMP programs, and quality systems.
• Active on local process teams or indirect participation through project support activities.
• Review and approve GMP documentation, including procedures, deviations, technical reports, and change controls occurring within the device assembly and packaging areas to ensure compliance with Lilly Global Quality Standards and regulatory requirements.
• Work cross-functionally with process teams for metrics reviews, operational support, and deviation management.
• 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 / observations, procedures, technical studies, validation protocols, change controls, and engineering documents).
• Participate in projects to help improve productivity within the local process team or quality organization.
• Network with global device assembly and packaging sites to share best practices, improve processes and resolve product-related issues.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for 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
• Number of Employees: 5,001-10,000 employees