QA - Stat Sort Specialist

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.

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.

• 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.

• 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

• 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

• 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.

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