Eli Lilly and Company · 21 hours ago
R&D Analytical Quality Assurance Representative
US, Indianapolis IN
Full-time
Onsite
Entry, Mid Level
$65K/yr - $148K/yr
2+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. The R&D Quality Assurance Analytical Representative ensures organizational alignment with business strategy and oversees laboratory activities to maintain compliance with quality standards and Good Manufacturing Practices (cGMP). This role involves quality oversight, documentation review, and facilitating quality improvement initiatives.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Provide QA oversight for R&D laboratories, R&D CPs and R&D GMP Service Providers as required
Provide quality oversight commiserate with primary loop responsibilities, namely molecule support (internal and external testing labs), analytical equipment support, audit support, periodic lab walkthroughs, and quality assessments of quality documentations
Ensure that appropriate Quality Systems are in place and are being utilized. Facilitate quality improvement initiatives, and the implementation of new quality standards
When necessary, evaluate potential impact of incidents on the quality of materials, or the integrity of data
Ensure appropriate investigations are conducted for deviations, stability failures and out of specification (OOS) results. Review and approval of the corresponding documentation
Perform Quality Assurance review and/or approval /rejection of GMP documentation and ensure that review/approval by appropriate technical experts has occurred
Be available for consultation on quality-related issues as needed
Provide quality oversight to ensure compliance with internal standards and applicable regulations by maintaining a regular presence in R&D areas and performing internal audits as scheduled
Qualification
Required
Bachelor's required – Preferred degree in Pharmacy, Chemistry, Life Sciences, Engineering, or related scientific discipline
Minimum 2 years of quality experience, (pharmaceutical experience preferred)
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 and/or visas for this role
Preferred
Experience in Quality Assurance/Control, Technical Services, Laboratory, Development, or Manufacturing desirable
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
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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