Scientist - QA

Eli Lilly and Company • Research Triangle Park, NC

2d • Onsite

About The Position

The Scientist - QA 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. The Scientist- QA position is essential for maintaining GMP compliance and providing support during preparation for General Inspections by various regulatory agencies. Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced Quality Assurance Representative for the Device Assembly and Packaging areas to support our growth in Research Triangle Park state-of-the-art facility production site. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

Requirements

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or related field.
• 5+ years of experience in Quality Assurance
• Demonstrated strong experience and proficiency with pharmaceutical manufacturing and working knowledge of Quality Management Systems and applicable regulatory requirements.
• Demonstrated attention to detail and ability to maintain quality systems.
• Previous experience working effectively with a cross-functional group.
• Demonstrated strong technical aptitude and ability to train and mentor others.
• Demonstrated decision making and problem-solving skills.
• Demonstrated ability to organize and prioritize multiple tasks.
• Demonstrated strong oral and written communication and interpersonal skills.

Nice To Haves

• Previous experience with highly automated device assembly and/or packaging processes.
• Previous experience with Manufacturing Execution Systems and electronic batch release.
• CQM, CQE, or CQA certification from the American Society for Quality (ASQ).
• Previous experience with Trackwise, SAP, Veeva, etc.
• Experience with US/EU regulations and notified bodies.

Responsibilities

• Responsible for adhering to safety rules and maintaining a safe work environment by supporting HSE corporate and site goals.
• Lead, mentor, and coach QA floor teams, operations, and support personnel, fostering a culture of safety, quality, compliance, and continuous improvement.
• 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.
• Ability to assess and triage deviations that occur within the device assembly and packaging areas.
• 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).
• Work with Lilly support groups and external partners to resolve or provide advice on product related issues.
• Participate in self-led inspections and provide support during internal / external regulatory inspections.
• Provide continuous quality improvement oversight to regulated processes, practices, and documentation.
• Review and approve GMP documentation, including procedures, deviations, technical reports, and change controls to ensure compliance with Lilly Global Quality Standards and regulatory requirements.
• Network with global device assembly and packaging sites to share best practices, improve processes and resolve product-related issues.
• Work cross-functionally with process teams for metrics reviews, operational support, and deviation management.
• Provide guidance and share technical knowledge in operational areas to ensure robust Quality Systems and GMP compliance.
• Participate in inspections from regulatory agencies and corporate audits, and manage responses to findings.
• Ensure compliance with corporate, local, and regulatory agency policies, procedures, and guidelines.
• Provide QA oversight of device assembly and packaging operations.
• Lead or participate in non-routine investigations, root cause analysis, and corrective/preventive actions.

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: Senior