Quality Assurance Senior Specialist - Statistical Sorting

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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 work worldwide to discover and bring life-changing medicines to those in need, improve disease understanding and management, and give back through philanthropy and volunteerism. We prioritize people and strive to make a positive impact.

Position Overview

Lilly is expanding its manufacturing footprint globally, including in Kenosha County, Wisconsin, to meet patient needs and support our innovative future. We seek experienced quality assurance associates to support this growth, offering a unique opportunity to implement new manufacturing investments and pioneering technologies.

The QA – Stat Sort Sr. Specialist will oversee daily operations of the Stat Sort group, develop QA Stat Sort Assistants, manage batch scheduling, and assist in deviation investigations, change control proposals, procedures, and training. The role also involves supporting the start-up, commissioning, and qualification of the Kenosha site, serving as an inspection SME resource.

Responsibilities

• Maintain a safe work environment, lead safety initiatives, and support all HSE goals.
• Manage Syringe Defect Kits, including Automated Inspection Challenge kits and Inspection Qualification kits.
• Act as a leader in the absence of the supervisor.
• Assist in developing QA Stat Sort Assistants.
• Plan and schedule QA Stat Sort operations; serve as a technical resource.
• Review GMP documents such as non-conformances, procedures, protocols, and change controls.
• Evaluate GMP-related incidents' impact on product quality; support investigations.
• Ensure compliance with documentation practices and operational procedures.
• Perform syringe inspections.
• Participate in Six Sigma projects and process improvement initiatives.
• Oversee and train new visual inspectors at the Parenteral site.

Basic Requirements

• High School diploma or equivalent.
• Relevant GMP facility experience.
• Strong interpersonal skills and teamwork ability.
• Organizational skills including planning and scheduling.
• Quick learner with new skills utilization.
• Autonomous and efficient work style.
• Positive attitude and flexibility.
• Proficiency in Microsoft Office.
• Ability to pass eye exam (20/20 vision, color blindness free).

Preferred Skills

• Parenteral visual inspection experience.
• Experience with deviation and change control processes.
• Background in Production, QC, QA, or Regulatory roles.
• Knowledge of cGMP, data integrity, and compliance.
• Mentoring or training experience.
• Strong communication skills.

Additional Information

• Location:
  
  Kenosha County, Wisconsin.
• Overtime and off-shift work may be required.
• Respond to operational issues outside core hours as needed.
• Mobility in various areas within the Parenteral Plant required.
• Post-offer exam may be required.
• Physical activity includes walking, sitting, bending, twisting, and lifting up to 30 lbs.

Lilly is committed to diversity and inclusion, providing accommodations during the application process. We are an EEO employer, welcoming applicants regardless of age, race, gender, or disability. Our employee resource groups support a diverse workforce. Compensation ranges from $17.30 to $39.06 per hour, with eligibility for bonuses and benefits.