Quality Assurance Senior Specialist - Statistical Sorting

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.

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.

Position Overview:

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future.  As a result, Lilly is looking for experienced quality assurance associates to support our growth in Kenosha County, Wisconsin. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The QA – Stat Sort Sr. Specialist will have oversight of the daily operations of the Stat Sort group, development of QA Stat Sort Assistants, daily batch scheduling, and will provide assistance in deviation investigations, change control proposals, procedures, training, and will be an inspection SME resource.  Additionally, the role will provide QA support of the start-up, commissioning, and qualification of the Kenosha site.

Responsibilities:

• Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
• Responsible for Syringe Defect Kit Management, including Automated Inspection Challenge kits, and Inspection Qualification kits.
• Capable of functioning in Leader capacity in absence of Leader.
• Assist Leader in development of QA Stat Sort Assistants.
• Participate in planning / scheduling of QA Stat Sort operations and be a technical leader / resource for QA Stat Sort Assistants.
• Review GMP documents (example: Non-conformances, procedures, protocols, and change controls).
• Evaluate potential Product Quality impact for any GMP-related incident and support the investigations and assist with Safety investigations.
• Ensure Good Documentation practices and compliance with operational procedures and work instructions with Operations and support personnel.
• Perform inspection of Syringes.
• Participates in Six Sigma Projects and Process Improvement Initiatives to improve productivity within the Quality organization and the process team.
• Provide oversight and assist with training of new Parenteral site visual inspectors.

Basic Requirements:

• High School diploma or equivalent
• Demonstrated relevant experience in a GMP facility.
• Demonstrated strong interpersonal skills and the ability to work as a TEAM.
• Demonstrated organizational skills (planning, scheduling, and ownership).
• Demonstrated ability to learn quickly and utilize new skills.
• Autonomous efficient worker.
• Positive attitude and flexible.
• Computer skills in Microsoft Office Products including Outlook.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Required to pass eye exam.  (20/20 correctible vision acuity and free of color blindness)

Additional Skills/Preferences:

• Parenteral visual inspection experience
• Previous experience with deviation and change control process.
• Experience in Production, QC, QA, Technical Services, or Regulatory
• Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance
• Experience as mentor or trainer
• Strong technical writing and oral/written communication skills

Additional Information:

• Primary location is Kenosha County, Wisconsin
• Ability to work overtime as required
• Overt