Eli Lilly and Company · 17 hours ago
Associate - IAPI QA
Indianapolis, IN
Full-time
Onsite
New Grad, Entry Level
$65K/yr - $169K/yrEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to making life better for people around the world. The Associate - IAPI QA role involves providing quality oversight for production and laboratory operations, ensuring compliance with quality systems and GMP regulations, and supporting various quality assurance activities.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Provide direct quality oversight of production, warehouse/material management, engineering, automation and laboratory operations
Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations
Provide quality guidance and recommendations with regard to manufacturing, materials, utilities, maintenance and laboratory issues
Participate in aberrant data investigations
Conduct analytical data review including stability data
Disposition API Intermediates and raw materials, as appropriate
Provide coaching, feedback and mentoring to QA Specialists as it relates to execution of quality systems
Investigate customer complaints
Participate in and/or support recalls, as appropriate
Contribute to and review Annual Product Reviews (APR), Quarterly Product and Process Self-Assessments (QPPA), laboratory periodic reviews and equipment/computer system periodic reviews, as appropriate
Conduct gap assessments of global requirements and ensure implementation of the governing standards
Participate in and/or lead self-inspection activities
Participate in and/or support regulatory inspections and audits
Maintain and improve quality systems
Assist others in the interpretation of regulatory and corporate requirements
Qualification
Required
BS in Engineering or a science-related field or equivalent experience
Must complete Learning Plan for Representative – QA – IAPI
No certifications required
Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE
Must support 24 hour/day operations
Preferred
Experience with computer system validation
Demonstrated strong written and verbal communications skills
Strong attention to detail
Proficiency with computer system applications
Knowledge of cGMPs and quality systems
Understanding of statistical tools and analysis
Excellent interpersonal skills and networking skills
Ability to organize and prioritize multiple tasks
Previous experience in QA, QC, Manufacturing, Engineering, Tech Services or Regulatory Affairs
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.
Founded in 1876
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
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 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
Company data provided by crunchbase