Scientist - IDAP Packaging QA Flow Mentor jobs in United States
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Eli Lilly and Company · 1 day ago

Scientist - IDAP Packaging QA Flow Mentor

Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to discovering and delivering life-changing medicines. The Scientist - IDAP Packaging QA Flow Mentor provides technical leadership and expertise in quality assurance, focusing on coaching QA floor representatives, supporting process optimization, and ensuring compliance with quality management systems.

BiotechnologyHealth CareMedicalPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Coach and mentor QA floor reps through onboarding and qualification
Coach and mentor QA floor reps in process understanding, problem solving, project management, and deviation resolution
Support and peer review root cause analysis around operational events
Promote and peer review documentation of learning points, gap assessments, and deviations
Provide technical support to non-routine investigations and lead investigations for the quality function
Work within cross-functional teams in a positive fashion to implement QA objectives and deliver on business plan and quality objectives
Provide process and equipment support through identification of systemic issues affecting production (deviations, cycle time delays, etc.)
Lead or participate in root cause analysis and countermeasure development and implementation for major compliance or throughput event investigations
Perform reviews of event documentation for technical accuracy and compliance
Provide back up and shutdown support for QA floor reps as needed
Identify and drive alignment of QA systems across IDAP
Support APR program
Support development and technical analysis for large-scale initiatives (secondary loop projects) such as productivity improvements, capacity development, GMP remediation, and safety risk mitigation
Review and identify opportunities for continuous improvement and assist in prioritization of opportunities with respect to overall business objectives
Collaborate with key support groups around the development of process knowledge and a common process improvement agenda
Provide independent peer input / review of technical activities
Provide support to the QA organization for deviation reduction and backlog prevention initiatives
Analyze process team metrics for awareness and identification of potential improvement opportunities

Qualification

Quality SystemsRoot Cause AnalysisProcess OptimizationCGMP KnowledgePharmaceutical Industry ExperienceTechnical WritingCommunication SkillsProblem-Solving SkillsTeam CollaborationAttention to DetailOrganizational Skills

Required

Bachelor's Degree or equivalent work experience
3 or more years in the pharmaceutical industry

Preferred

Demonstrated strong oral and written communication and interpersonal skills
Demonstrated decision making and problem-solving skills
Demonstrated knowledge and understanding of manufacturing process and Quality Systems
Demonstrated attention to detail
Demonstrated ability to organize and prioritize multiple tasks
Experience in Quality, TS/MS, or engineering is preferred
Experience in device assembly and packaging processes
Good knowledge of cGMP, external regulations and Lilly quality systems and requirements
Experience leading root cause investigations
Excellent technical writing skills
Ability to function in a team environment as a leader and as a member of teams
Ability to partner / network outside the IDAP site and participate in inspection readiness / continuous improvement initiatives

Benefits

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

Company

Eli Lilly and Company

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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

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