QA - Stat Sort Specialist

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

Benefits offered by this job

Company bonus program

401(k) plan

Medical benefits

Job summary

Lilly is designing a new Parenteral, Device Assembly, and Packaging Facility in Concord, North Carolina. The QA Specialist - Stat Sort will perform 100% manual visual inspections, classify defects, and support QC labs with documentation and investigations.

Role requires attention to detail, GMP understanding, and ability to work with SAP/MES systems. Off-shift work and cross-area mobility may apply as part of site operations.

Qualifications

• High School Diploma or GED.
• Authorized to work in the United States on a full-time basis; visa sponsorship not provided.
• Experience in GMP facility preferred and knowledge of QA/QC processes.

Responsibilities

• Maintain a safe work environment and support site goals.
• Ensure Good Documentation practices and compliance with inspection documents.
• Complete manual visual statistical sorting inspection according to production schedule.
• Document defect classification information in manufacturing tickets.
• Deliver samples to laboratories and document results.
• Support training and qualification activities for inspection personnel.
• Assist investigations related to defect classification.

Skills

Attention to detail

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 appropriatesamples are delivered and documented to the QC Laboratories as well as documentingresults of the manual visual inspection results.

Responsibilities

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

• Ensure Good Documentation practices and compliance with inspection andoperational related documents.

• Complete manual visual statistical sorting inspection for Concord Parenteralproducts in alignment with production schedule.

• Document defect classification information within manufacturing ticket associatedwith 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 andqualification 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 goodcommunication skills, eye-hand coordination and manual skills. Occasionallyrequires 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 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.

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.