Eli Lilly and Company · 6 days ago
Sr. Scientist-Mfg. Quality Assurance (Night Shift)
US, Pleasant Prairie WI
Full-time
Onsite
Mid, Senior Level
$65K/yr - $169K/yr
3+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. They are seeking a Senior Scientist for Quality Assurance to provide oversight for GMP operations, ensuring compliance and inspection readiness while collaborating across various teams to resolve issues and support manufacturing processes.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals
Follows good documentation practices and compliance with site procedures
Leads, mentors, and coaches the operations and support personnel on quality matters
Ensures regular presence in operational areas to monitor GMP programs and quality systems
Assess and triages deviations that occur within the local process team
Works with Lilly support groups and external partners to resolve or provide advice on product related issues
Participates in self-led inspections and provides support during regulatory inspections
Initiates, reviews, and approves documents to ensure quality attributes are met (e.g., deviations, procedures, technical studies, validation protocols, change controls, engineering documents)
Participates in continuous improvement projects to help improve productivity within the local process team or quality organization
Approves commissioning, qualification, and validation documents for computer systems and equipment to ensure compliance with quality standards
Networks with Global Parenteral Network sites to benchmark and replicate best practices
Qualification
Required
Bachelor's degree in science, engineering, or pharmaceutical-related field of study
Minimum 3 years in the pharmaceutical industry with specific batch disposition experience
On-site presence required
Preferred
Demonstrated understanding of cGMP regulations and experience in GMP production environments
Previous experience with C&Q and Validation oversight, including automation and computer systems validation
Knowledge and application of US, EU, Japan, and other pharmaceutical manufacturing regulations
Proficiency with applicable computer systems and Manufacturing Execution Systems
Experience with Computer System Quality Assurance (CSQA) and electronic validation software (e.g., KNEAT)
Strong oral and written communication skills, including technical writing
Demonstrated interpersonal skills and ability to work effectively in a team environment
Ability to perform root cause analysis/troubleshooting and maintain quality systems with attention to detail
Proven ability to work independently or collaboratively to resolve issues
ASQ Certification
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
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
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
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Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
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