Scientist - QA Floor Support

Eli Lilly and Company; Indianapolis (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading healthcare company in Indianapolis is seeking a Scientist for QA Floor Support. This role involves providing oversight on quality matters, ensuring GMP compliance, and collaborating with teams on product issues. Ideal candidates will have a degree in Science or Engineering and experience in a GMP environment. Strong communication and decision-making skills are essential, as is the ability to work independently and in teams.

Qualifications

• Experience in a GMP environment or equivalent.
• Experience in GMP production or QCL is desirable.

Responsibilities

• Lead and mentor operations on quality matters.
• Monitor GMP programs and quality systems.
• Participate in inspections and support regulatory reviews.

Skills

Communication

Decision-making

Problem-solving

Attention to detail

Education

Bachelor's degree in Science or Engineering

Tools

MS Office

Regulus

TrackWise

PMX

SAP

Job description

Join to apply for the Scientist - QA Floor Support role at Eli Lilly and Company

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 work to discover and bring medicines to those in need, improve disease understanding and management, and give back through philanthropy and volunteerism. We prioritize people and our best efforts to make life better.

Organization Overview

The QA Floor Support team member provides daily oversight, assistance, and guidance on issues such as non-conformance investigations, change control proposals, procedure/master formula revisions, validations, batch disposition, commissioning, and qualification activities. They advise and support other QA Representatives. This role is essential for GMP compliance and supporting regulatory inspections.

Responsibilities

1. Adhere to safety rules and maintain a safe work environment supporting HSE goals.
2. Lead, mentor, and coach operations and support personnel on quality matters.
3. Monitor GMP programs and quality systems in operational areas.
4. Participate in local process teams and project support activities.
5. Assess and triage deviations/observations within the process team.
6. Collaborate with Lilly support groups and external partners on product issues.
7. Participate in inspections and support during regulatory reviews.
8. Review and redline documents to ensure quality standards are met.
9. Participate in Six Sigma projects to improve productivity.
10. Support project and process improvements as a Quality representative.
11. Approve commissioning, qualification, and validation documents for compliance.
12. Network with global sites for benchmarking and resources.

Basic Requirements

• Bachelor's degree, preferably in Science or Engineering.
• Experience in a GMP environment or equivalent.

Additional Skills/Preferences

• Strong communication and interpersonal skills.
• Decision-making and problem-solving abilities.
• Knowledge of manufacturing processes and Quality Systems.
• Technical writing skills.
• Ability to work independently and in teams.
• Attention to detail.
• Experience in GMP production or QCL is desirable.
• Experience with Lilly's Event and Change Management processes.
• Proficiency in MS Office, Regulus, TrackWise, PMX, SAP.

Additional Information

• Overtime may be required.
• Respond to operational issues outside core hours.
• Role based in Indianapolis, onsite required.
• Consider allergen exposure and mobility requirements.
• Post-offer exams may be required.

Lilly supports individuals with disabilities and provides accommodations upon request. We are an EEO employer, promoting diversity and inclusion through employee resource groups.