Scientist - QA Floor Support

Eli Lilly and Company; Indianapolis (IN); On-site; USD 63,000 - 141,000; Full time

Job summary

A leading healthcare company is seeking a QA Representative for the Floor Support team in Indianapolis. This role involves overseeing quality assurance processes, mentoring staff, and ensuring compliance with GMP standards. The ideal candidate will have a strong background in science or engineering, excellent communication skills, and experience in GMP environments. The position requires onsite presence and involves collaboration with various teams to enhance quality systems and processes.

Benefits

Comprehensive benefits

401(k)

Pension

Health coverage

Flexible spending accounts

Insurance

Wellness programs

Qualifications

• Bachelor's degree or equivalent experience in a GMP facility.
• Experience in GMP environments or QCL is desirable.

Responsibilities

• Lead and mentor operations personnel on quality matters.
• Collaborate with support groups to resolve product-related issues.
• Participate in inspections and support regulatory inspections.

Skills

Communication

Interpersonal

Decision-making

Problem-solving

Attention to detail

Education

Bachelor’s degree in Science or Engineering

Tools

Microsoft Office

Regulus

TrackWise

PMX

SAP

Job description

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 through philanthropy and volunteerism. We prioritize our work and put people first. We seek individuals determined to improve lives globally.

Organization Overview:

The QA Representative for the Floor Support team provides daily oversight, assistance, and guidance on issues such as non-conformance investigations, change control proposals, procedure and master formula revisions, validations, batch disposition, commissioning, and qualification activities. They advise and support other floor support QA Representatives. This role is crucial for maintaining GMP compliance and supporting preparations for Pre-Approval and General Inspections by regulatory agencies.

Responsibilities:

1. Adhere to safety rules and support HSE goals to maintain a safe work environment.
2. Lead, mentor, and coach operations and support personnel on quality matters.
3. Maintain a presence in operational areas to monitor GMP programs and quality systems.
4. Participate in local process teams and project support activities as outlined in MSOE standards.
5. Assess and triage deviations and observations within the local process team.
6. Collaborate with Lilly support groups and external partners to resolve product-related issues.
7. Participate in self-led inspections and support during internal and external regulatory inspections.
8. Review and redline documents to ensure quality attributes are met, including deviations, procedures, studies, protocols, change controls, and engineering documents.
9. Participate in Six Sigma projects to enhance productivity.
10. Support project and process improvements for Plant Process Teams as a representative of Quality.
11. Approve commissioning, qualification, and validation documents for compliance.
12. Network with global sites for benchmarking and resource sharing.

Basic Requirements:

• Bachelor’s degree, preferably in Science or Engineering.
• Equivalent experience in a GMP facility.

Additional Skills/Preferences:

• Strong communication, interpersonal, decision-making, and problem-solving skills.
• 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, and SAP.

Additional Information:

• Overtime may be required.
• Responding to operational issues outside core hours may be necessary.
• Position based at LTC-S, Indianapolis, IN, requiring onsite presence.
• Work may involve exposure to allergens; mobility requirements should be considered.
• Post-Offer Exam may be required.

Lilly is committed to accommodating individuals with disabilities. If you need assistance with your application, please complete the Workplace Accommodation Request Form. We are an equal opportunity employer and do not discriminate based on age, race, religion, gender, or other protected statuses.

Our employee resource groups include various networks such as Africa, Middle East, Black Employees, Chinese Culture, JILN, Lilly India, Latinx, PRIDE, Veterans, Women’s Initiative, enAble, and more. Learn more about them on our website.

Compensation for this role ranges from $63,000 to $140,800, depending on education, experience, skills, and location. Full-time employees are eligible for bonuses, comprehensive benefits, 401(k), pension, health coverage, flexible spending accounts, insurance, and wellness programs. Lilly reserves the right to modify these programs.

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