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 an kommerziellen sowie entwicklungsbezogenen Produkten durchführt. Diese Rolle erfordert fundierte Kenntnisse in Qualitätssystemen und regulatorischen Anforderungen, um sicherzustellen, dass die Produkte den höchsten Standards entsprechen. Sie werden an spannenden Projekten teilnehmen, die sich auf neue Produktdesigns und Prozessverbesserungen konzentrieren. Wenn Sie eine Leidenschaft für Qualität und die Fähigkeit haben, in einem dynamischen Umfeld zu arbeiten, ist dies die perfekte Gelegenheit für Sie.

Benefits

401(k)

Pensionsplan

Gesundheitsleistungen

Flexible Ausgaben

Lebensversicherung

Bezahlter Urlaub

Wellness-Programme

Qualifications

• Mindestens 5 Jahre Erfahrung in der regulierten Industrie mit Kenntnissen über Qualitätssysteme.
• Erfahrung mit parenteralen Produkten oder Geräten ist erforderlich.

Responsibilities

• Entwicklung und Pflege von Qualitätskontrollsystemen im IDM QC-Labor.
• Durchführung von Tests und Unterstützung bei Laboruntersuchungen.

Skills

Qualitätskontrolle

Analytische Fähigkeiten

Problemlösungsfähigkeiten

Teamarbeit

Selbstmotivation

Kommunikationsfähigkeiten

Education

Bachelor-Abschluss in einem relevanten Bereich

Tools

Veeva Vault

Trackwise

Microsoft Office Suite

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 worldwide 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 prioritize our work and put people first. We seek individuals committed to improving lives globally.

Organization Overview:

The QC Lab Technician, Device Quality, is responsible for providing technical support for laboratory operations, performing testing on commercial and developmental 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 applications.
2. Implement, maintain, and enhance quality systems within the IDM QC laboratory.
3. Provide Quality Control support for the IDM QC laboratory.
4. Author, maintain, and instruct on OJT courses for laboratory equipment, testing, inspection, and operations.
5. Perform and oversee QC laboratory equipment setup, operation, and maintenance.
6. Build and maintain relationships with DDR&D, TS/MS, Lilly final Device Assembly/Packaging Sites, and Contract Manufacturers supporting batch release testing.
7. Participate in new product design and pre-launch projects to support laboratory operations and device testing.
8. Participate in process improvement activities.
9. Maintain IDM QC laboratory inventory.
10. Assist in equipment qualification testing including IQ, OQ, and PQ.
11. Maintain and manage the reference sample retention area.
12. Support and perform laboratory device testing for products using good documentation practices.
13. Perform test equipment setup, operation, and maintenance.
14. Support shipping and receiving activities as assigned.
15. Create/Edit lot release workshops as needed.
16. Maintain laboratory notebooks, including authoring, revision, and retirement.
17. Participate in regulatory agency and internal inspections.
18. Ensure test equipment is validated and maintained for its intended use.
19. Support Event Management roles related to deviations impacting the QC laboratory, including origination of SARE as appropriate.
20. Support Change Management tasks and implementation steps.

Basic Requirements:

• Minimum of 5 years of regulated industry experience with knowledge of quality systems and regulatory requirements (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 verbal and written communication skills in English.
• Self-motivated and able to work independently.
• Proficient in Outlook, Windows, and Microsoft applications.
• Good teamwork and multi-tasking abilities.
• Curiosity and ability to question and resolve issues.
• Critical thinking and problem-solving skills with rationale application.

Additional Skills/Preferences:

• Three years of experience in Quality, QC Lab, or TS/MS support.
• Attention to detail.
• Experience with Microsoft Office Suite and LillyNet Collaboration Sites.
• Knowledge of federal regulations applicable to the pharmaceutical industry.
• Ability to mentor and train others.

Additional Information:

Lilly is committed to providing accommodations for individuals with disabilities during the application process. If needed, complete the workplace accommodation request form.

We are an equal opportunity employer, valuing diversity and inclusion.

Compensation for this role ranges from $17.30 to $39.06 per hour, based on education, experience, skills, and location. Benefits include a 401(k), pension, health benefits, flexible spending accounts, life insurance, paid time off, and well-being programs. Compensation practices and benefits are subject to change at Lilly's discretion.

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