QA - Stat Sort Specialist

Eli Lilly and Company; Concord (NC); On-site; USD 25,000 - 48,000; Full time

Job summary

Lilly in Concord, North Carolina is seeking a QA Specialist – Stat Sort to perform manual visual inspections of 100% of Parenteral product units and support final defect classification and investigations.

You will also train inspection Operators, ensure proper sampling to QC laboratories, and maintain strict documentation practices in a GMP environment. The role may involve off-shift support.

Qualifications

• 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.

Responsibilities

• Maintain a safe work environment and support HSE goals.
• Ensure Good Documentation practices and compliance with inspection and operational documents.
• Complete manual visual statistical sorting inspection for Concord Parenteral products in alignment with production schedule.
• Document defect classification information within manufacturing tickets.
• Ensure sampling of final semi-finished product and deliver samples to laboratories with documentation.
• Support training and qualification activities for inspection personnel.
• Assist Operations with defect classification investigations.

Skills

Attention to detail

QA/QC experience

GMP experience

Organizational skills

MS Office, SAP, MES

Job description

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 down stairs.

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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