QC Lab Technician

Eli Lilly and Company; Indianapolis (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen QC Lab Technician, der technische Unterstützung für Laboroperationen bietet und Tests für Produkte durchführt. In dieser Rolle werden Sie für die Implementierung und Verbesserung von Qualitätssystemen verantwortlich sein und eng mit verschiedenen Abteilungen zusammenarbeiten, um sicherzustellen, dass alle Produkte den höchsten Standards entsprechen. Sie werden auch an neuen Produktdesigns und Prozessverbesserungen beteiligt sein. Wenn Sie eine Leidenschaft für Qualität und Detailgenauigkeit haben und in einem dynamischen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Benefits

401(k)

Pensionsplan

Gesundheitsleistungen

Flexible Ausgaben

Lebensversicherung

Wellness-Programme

Bonussystem

Qualifications

• Mindestens 5 Jahre Erfahrung in der regulierten Industrie.
• Kenntnisse über Qualitätssysteme und Vorschriften wie cGMP und ISO.
• Starke Problemlösungs- und analytische Fähigkeiten.

Responsibilities

• Unterstützung der Laborbetriebe und Durchführung von Tests.
• Implementierung und Verbesserung von Qualitätssystemen.
• Aufbau von Beziehungen zu anderen Abteilungen für Tests.

Skills

Qualitätssysteme und Vorschriften

Problemlösungsfähigkeiten

Analytische Fähigkeiten

Kommunikationsfähigkeiten

Eigenmotivation

Teamarbeit

Kritisches Denken

Education

5 Jahre Erfahrung in regulierter Industrie

Tools

Veeva Vault

Trackwise

Microsoft Office Suite

LillyNet

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 committed to enhancing lives globally.

Organization Overview:

The QC Lab Technician, Device Quality, is responsible for providing technical support for laboratory operations, performing testing for commercial and development products, and supporting laboratory investigations.

Responsibilities:

1. Develop and maintain knowledge of applicable regulations, LQS, and GQS requirements to influence Lilly’s and the industry’s application.
2. Implement, maintain, and improve quality systems within the IDM QC laboratory.
3. Provide Quality Control support for the laboratory.
4. Create, maintain, and instruct on OJT courses for laboratory equipment, testing, inspection, and operations.
5. Oversee QC laboratory equipment setup, operation, and maintenance.
6. Build relationships with supporting departments and contract manufacturers for batch release testing.
7. Participate in new product design and pre-launch projects to support laboratory operations and device testing.
8. Engage in departmental process improvements.
9. Manage IDM QC laboratory inventory.
10. Assist in equipment qualification activities such as IQ, OQ, and PQ.
11. Maintain the reference sample retention area.
12. Support and perform laboratory device testing using good documentation practices.
13. Perform test equipment setup, operation, and maintenance.
14. Support shipping and receiving as needed.
15. Create or edit lot release workshops.
16. Maintain laboratory notebooks, including documentation and revisions.
17. Participate in regulatory and internal inspections.
18. Ensure test equipment validation and maintenance.
19. Support Event Management and Change Management activities related to laboratory deviations and tasks.

Basic Requirements:

• At least 5 years of regulated industry experience with knowledge of quality systems and regulations (e.g., cGMP, 21 CFR 820, ISO 13485, ISO 14971, MDR, EU Medical Device Directive, JPAL).
• Strong problem solving and analytical skills.
• Experience with Parenteral products, dry products, or devices.
• Experience with Veeva Vault and Trackwise.
• Excellent communication skills in English.
• Self-motivated and able to work independently.
• Proficient in Outlook, Windows, and Microsoft applications.
• Team-oriented with multitasking abilities.
• Curiosity and critical thinking skills to identify and resolve issues.

Additional Skills/Preferences:

• Three years of experience supporting Quality, QC Lab, or TS/MS.
• Attention to detail.
• Proficiency with Microsoft Office Suite and LillyNet.
• Knowledge of federal regulations relevant to pharmaceuticals and quality systems.
• Ability to mentor and train others.

Additional Information:

Lilly is committed to providing accommodations for individuals with disabilities during the application process. For assistance, complete the accommodation request form. We are an EEO employer and do not discriminate based on age, race, religion, gender identity, sexual orientation, disability, or other protected statuses.

Our employee resource groups include networks for various cultural, identity, and interest groups. Learn more about them on our website.

Compensation varies based on education, experience, skills, and location. The expected wage range is $17.30 - $39.06 per hour. Full-time employees are eligible for bonuses and a comprehensive benefits package, including 401(k), pension, health benefits, flexible spending accounts, life insurance, and wellness programs. Lilly may modify its compensation and benefits policies at its discretion.

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