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Initial Therapeutics, Inc. is hiring: Quality Assurance Specialist - Visual Insp

Initial Therapeutics, Inc.
Pleasant Prairie, WI Full Time
POSTED ON 2/4/2025
AVAILABLE BEFORE 5/2/2025

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $17.30 - $39.06.

Position Description :

The QA Stat Sort Specialist is responsible for providing manual visual inspection of the 100% inspection Parenteral product units. The QA Stat Sort Specialist provides support to Operations related to final classification of defects and routine defect investigations. The QA Stat Sort Specialist ensures appropriate samples are delivered and documented as well as documenting results of the manual visual inspection results.

Key Objectives / Deliverables :

  • Ensure regular presence in operational areas to monitor GMP programs and quality systems including various inspection activities.
  • Complete manual visual statistical sorting inspection for Parenteral products in alignment with production schedule.
  • Document defect classification information within batch record associated with statistical inspection.
  • Ensure appropriate sampling of final semi-finished product, delivering the samples to the appropriate laboratories and completing all associated documentation.
  • Ensure Good Documentation practices and compliance with inspection and operational related documents.
  • Support Operational inspection personnel with completion of required training and qualification activities.
  • Support Operations and investigations related to appropriate classification of defects.
  • Support inspection readiness activities.
  • Ensure data integrity by design.
  • Pass an annual vision test and be free of color blindness.
  • Must be equivalent to 20 / 20 correctable close vision acuity.

Additional Preferences :

  • Ability to work independently or as part of a team to resolve issues.
  • Strong attention to detail and ability to make decisions in support of quality and compliance within the manufacturing environment.
  • Experience in GMP production environments is desirable (operations, QA).
  • Proficiency with computer systems including Microsoft Office products, TrackWise, and SAP.
  • Demonstrate strong oral and written communication and interpersonal skills.
  • Demonstrated decision making and problem-solving skills.
  • Demonstrate knowledge and understanding of manufacturing process and Quality Systems.
  • Education :

  • Bachelor's degree in science or equivalent experience.
  • 1-3 years of relevant experience. Pharmaceutical preferred.
  • Other Information :

  • Night shift.
  • Ability to work overtime as required.
  • Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
  • This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

    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 for further assistance.

    Lilly is an EEO / Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

    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).

    WeAreLilly

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    Salary : $17 - $39

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