QA - Stat Sort Specialist

Regulatory Jobs; Concord (NC); On-site; USD 25,000 - 48,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Vacation benefits

Comprehensive benefits

Job summary

Lilly in Concord, North Carolina, is seeking a QA Specialist – Stat Sort to perform manual visual inspection of Parenteral product units and support defect classification and investigations. You’ll help train inspection operators and ensure samples are delivered to QC with proper documentation.

The role requires attention to detail, GMP experience, and proficiency with SAP/MES; the team offers a safety‑conscious work environment with comprehensive benefits and a strong commitment to patient

Qualifications

• High school diploma or GED is required.
• Authorized to work in the United States on a full-time basis; no visa sponsorship provided.
• Experience in GMP facilities is preferred.
• Strong attention to detail and organizational skills; ability to document clearly.

Responsibilities

• Perform manual visual inspection of 100% of Parenteral product units.
• Classify defects and support routine defect investigations.
• Assist in training and qualification of inspection operators.
• Deliver samples to QC Laboratories with proper documentation.
• Support calculations and documentation of results from manual inspections.
• Assist with defect investigations and operational inspections.

Skills

Attention to detail

GMP experience

QA/QC

Organizational skills

Education

High School Diploma or GED

Tools

SAP

MES

Microsoft Office

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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

• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
• 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

• High School Diploma or GED.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Additional Preferences

• Strong Attention to detail
• Experience in Pharmaceutical Production, QA or QC is desirable
• Demonstrated relevant experience in a GMP facility
• Demonstrated organizational skills
• Proficiency with computer systems including Microsoft Office products, SAP and MES

Other Information

• Position may be required to support off shift activities
• Applicant may work in various areas within the Parenteral Plant.
• Mobility requirements should be considered when applying for this position.
• May be subject to Post Offer Exam
• Must be able to differentiate between colors.
• Must be able to perform tasks requiring near‑vision clarity equivalent to 20/20 at close range, with or without corrective lenses.
• Physical Demands: Light work that requires physical effort. Requires good communication skills, eye-hand coordination and manual skills. Occasionally requires force to raise, to load, and to push objects. Occasionally requires movements of the body like: to incline, to climb, to kneel, to bend, to rise, and to walk downstairs.

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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

$18.02 - $34.90

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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