Scientist - QA

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

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.

Position Description:
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.

Key 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.

Technical Responsibilities

· 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.

Minimum 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.

Additional Preferences:

· 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