QC Lab Technician

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

Job summary

Join a leading healthcare firm as a QC Lab Technician, where you'll play a pivotal role in ensuring product quality and compliance. This position offers the chance to engage in laboratory operations, support quality control processes, and work on exciting new product designs. With a focus on teamwork and innovation, you'll contribute to making a positive impact in the healthcare industry. The role requires strong analytical skills and a commitment to quality, making it perfect for individuals eager to advance their careers in a dynamic environment. Embrace the opportunity to be part of a company that values diversity and inclusion while providing comprehensive benefits and a supportive work culture.

Benefits

401(k)

Health Insurance

Flexible Spending Accounts

Life Insurance

Well-being Programs

Qualifications

• 5+ years of experience in regulated industry with quality systems knowledge.
• Strong analytical and problem-solving skills are essential.
• Experience with parenteral products or devices preferred.

Responsibilities

• Maintain quality systems and support laboratory operations.
• Perform QC testing and oversee lab equipment maintenance.
• Participate in regulatory inspections and process improvements.

Skills

Quality Control

Analytical Skills

Problem-Solving

Communication Skills

Regulatory Knowledge

Teamwork

Critical Thinking

Tools

Veeva Vault

Trackwise

Microsoft Office Suite

Outlook

Windows

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 medicines to those in need, improve disease management, and give back to communities through philanthropy and volunteerism. We prioritize our work and put people first. We seek individuals determined to make a positive impact globally.

Organization Overview:

The QC Lab Technician, Device Quality, is responsible for providing technical support for laboratory operations, performing testing on 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 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 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. Participate in process improvement activities and maintain laboratory inventory.
9. Assist in equipment qualification testing activities including IQ, OQ, and PQ.
10. Maintain and manage the reference sample retention area.
11. Support and perform laboratory device testing using good documentation practices.
12. Perform test equipment setup, operation, and maintenance.
13. Support shipping and receiving activities.
14. Create or edit lot release workshops as needed.
15. Maintain laboratory notebooks, including authoring, revision, and retirement.
16. Participate in regulatory and internal inspections.
17. Ensure proper validation and maintenance of test equipment.
18. Support Event Management and Change Management processes related to deviations 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 communication skills in English.
• Self-motivated and able to work independently.
• Proficient in Outlook, Windows, and Microsoft applications.
• Ability to multitask and work well in teams.
• Curiosity and ability to question issues and work towards resolution.
• Strong critical thinking and problem-solving skills.

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 related to the pharmaceutical industry and quality systems.
• Ability to mentor and train others.

Additional Information:

Lilly is committed to accommodating individuals with disabilities during the application process. For accommodation requests, please complete the workplace accommodation form. Lilly is an EEO employer, promoting diversity and inclusion.

Our employee resource groups (ERGs) support diverse communities within Lilly, including groups for different regions, identities, and interests. Learn more about our ERGs.

Compensation for this position ranges from $17.30 to $39.06 per hour, depending on experience and location. Full-time employees are eligible for bonuses and a comprehensive benefits package, including 401(k), health insurance, flexible spending accounts, life insurance, and well-being programs. Lilly reserves the right to modify compensation and benefits policies.

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