Scientist - QA Floor Support

BioSpace; Indianapolis (IN); On-site; USD 63,000 - 141,000; Full time

Job summary

A global healthcare leader in Indianapolis seeks a Scientist - QA Floor Support to oversee quality assurance processes, mentor staff, and ensure compliance with GMP standards. This role involves collaboration with various teams and participation in regulatory inspections. The ideal candidate has a strong scientific background, excellent communication skills, and experience in GMP environments.

Benefits

401(k)

Pension

Health Benefits

Qualifications

• Bachelor’s degree in Science or Engineering preferred.
• Equivalent GMP experience.

Responsibilities

• Ensure safety rules are followed and maintain a safe work environment.
• Lead, mentor, and coach operations and support personnel on quality matters.
• Participate in inspections and support during regulatory reviews.

Skills

Communication

Decision Making

Problem Solving

Attention to Detail

Education

Bachelor’s degree in Science or Engineering

Tools

Microsoft Office

Regulus

TrackWise

PMX

SAP

Job description

Join to apply for the Scientist - QA Floor Support role at BioSpace.

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 life-changing medicines to those in need, improve disease understanding and management, and give back to communities through philanthropy and volunteerism. We are committed to our work and to putting people first.

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 vital for maintaining GMP compliance and supporting pre-approval and regulatory inspections.

Responsibilities

1. Ensure safety rules are followed and maintain a safe work environment supporting HSE goals.
2. Lead, mentor, and coach operations and support personnel on quality matters.
3. Regularly monitor GMP programs and quality systems in operational areas.
4. Participate in local process teams and 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. Engage in Six Sigma projects to improve productivity.
10. Support project and process improvements for Plant Process Teams.
11. Approve validation documents for computer systems and equipment.
12. Network with global sites for benchmarking and resource sharing.

Basic Requirements

• Bachelor’s degree in Science or Engineering (preferred).
• Equivalent GMP experience.

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 environments or QCL is desirable.
• Experience with Lilly Event and Change Management processes.
• Proficiency with Microsoft Office, Regulus, TrackWise, PMX, SAP.

Additional Information

• Overtime may be required.
• Respond to operational issues outside core hours.
• Position based at LTC-S, Indianapolis, IN, onsite required.
• Work may involve exposure to allergens and mobility considerations.
• Post-offer exam may be required.

Lilly is committed to diversity and equal opportunity. Accommodation requests can be made through our workplace accommodation form. Compensation depends on experience and location, with an estimated range of $63,000 - $140,800. Benefits include a 401(k), pension, health benefits, and more.