Quality Assurance Senior Specialist - Statistical Sorting

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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.

Minimum 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)

• 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.

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

• Overtime and off-shift support may be required.

• May be required to respond to operational issues outside of core business hours and days.

• 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.

• Job is exposed to repetitive movements such as: Walking, Sitting, Bending, Twisting, etc.

• Ability to lift 30 lbs.

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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $18.02 - $34.90

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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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