Quality Assurance Senior Specialist - Statistical Sorting

Eli Lilly and Company • Pleasant Prairie, WI

4d • Onsite

About The Position

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.

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.

Nice To Haves

• 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

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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental and 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED