QA - Stat Sort Specialist

LillyConcord, NC
$18 - $35Onsite

About The Position

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.

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 and 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
  • 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.

Nice To Haves

  • 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

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.

Benefits

  • company bonus (depending, in part, on company and individual performance)
  • company-sponsored 401(k)
  • pension
  • vacation benefits
  • 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
  • well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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