Quality Assurance Senior Specialist - Statistical Sorting jobs in United States
cer-icon
Apply on Employer Site
company-logo

Eli Lilly and Company · 2 days ago

Quality Assurance Senior Specialist - Statistical Sorting

Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and delivering life-changing medicines. They are seeking a Quality Assurance Senior Specialist to oversee daily operations of the Stat Sort group, assist in training, and ensure compliance with quality standards at their Kenosha County, Wisconsin site.

BiotechnologyHealth CareMedicalPharmaceutical
check
H1B Sponsor Likelynote

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

Qualification

GMP experienceCGMP practices knowledgeParenteral visual inspectionTechnical writingOral/written communicationComputer skillsInterpersonal skillsOrganizational skillsTeamworkMentoring experience

Required

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)

Preferred

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

Benefits

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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Company

Eli Lilly and Company

company-logo
We're a medicine company turning science into healing to make life better for people around the world.

H1B Sponsorship

Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)

Funding

Current Stage
Public Company
Total Funding
$6.5M
2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO

Leadership Team

leader-logo
David Ricks
Chair, CEO
linkedin
leader-logo
Lucas Montarce
Executive Vice President and Chief Financial Officer
linkedin
Company data provided by crunchbase