QA Specialist – Stat Sort

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 around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview:

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility in Concord, North Carolina.  This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. 

Role Description:

The QA Specialist – Stat Sort is responsible for providing manual visual inspection of the 100 % inspection Parenteral product units. The QA Specialist – Stat Sort provides support to Operations related to final classification of defects and routine defect investigations. 
The QA Specialist – Stat Sort also supports training and qualification of inspection Operators within Concord Parenteral Operations. The QA Specialist– Stat Sort ensures appropriate samples are delivered and documented to the QC Laboratories as well as documenting results of the manual visual inspection results.

Responsibilities:

• Ensure Good Documentation practices and compliance with inspection and operational related documents. 
• Complete manual visual statistical sorting inspection for Concord Parenteral products in alignment with production schedule. 
• Document defect classification information within manufacturing ticket associated with statistical inspection. 
• Ensure appropriate sampling of final semi-finished product, delivering the samples to the appropriate laboratories and completing all associated documentation 
• Support Operational inspection personnel with completion of required training and qualification activities. 
• Support Operations and investigations related to appropriate classification of defects.

Minimum Requirements:

• Demonstrated experience in a GMP facility 
• Demonstrated organizational skills 
• Proficiency with computer systems including Microsoft Office products, SAP and MES 
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals 
• Pass an annual vision test and be free of color blindness. 
• Must be equivalent to 20 /20 correctable close vision acuity.

Additional Preferences:

• Strong Attention to detail 
• Experience in Pharmaceutical Production, QA or QC is desirable

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$17.30 - $39.06

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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