Scientist - QA

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 position is essential for maintaining GMP compliance and providing support during preparation for general inspections by various regulatory agencies.

• 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.
• Act as an active member of local process teams or provide indirect participation through project support activities.
• Assess and triage deviations that occur within the device assembly and packaging areas.
• Effectively review and/or redline to ensure quality attributes are met (e.g., 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.

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

• 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.

• The schedule for this position is Monday–Friday, day shift.
• After‑hours contact may be required for escalation issues.

• Salary range: $65,250 – $169,400 per year.
• Full‑time employees are eligible for a company bonus, depending on company and individual performance.
• Company‑sponsored 401(k) plan; pension; vacation benefits; medical, dental, vision, and prescription drug coverage; flexible benefits; life and death insurance; time‑off and leave of absence benefits; well‑being programs; and employee clubs and activities.

Lilly is an equal‑employment‑opportunity employer. We do not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.