Sr. Associate, QA Analytical (R2 – R3)

Posted 5 Days Ago
Be an Early Applicant
Indianapolis, IN, USA
In-Office
155K-178K Annually
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
Provide QA analytical oversight for PR&D and partners: audit labs, review GMP documentation and analytical data, assess deviations/change controls/OOS, support equipment validation (IQ/OQ/PQ), and implement quality improvements to ensure regulatory compliance.
Summary Generated by Built In

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 


Eli Lilly and Company seeks a Sr. Associate, QA Analytical (R2 – R3), to provide quality assurance analytical oversight for Product Research & Development (PR&D) and associated collaboration partners. Provide quality oversight for molecule testing labs, analytical equipment, perform audits and lab walkthroughs, and assessments of quality documentation and data. Ensure that quality systems are in place, utilized, and in a state of control. Facilitate quality improvement initiatives, and the implementation of new quality standards. Assess potential impact of incidents and ensure appropriate review is conducted for deviations, change controls, and out of specification results. Perform quality assurance review of GMP documentation and ensure compliance with internal standards and applicable regulations. #LI-DNI
Position requires a Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, Engineering, or a related field, and 4 years of experience with quality assurance and control in a pharmaceutical setting. Experience must include a minimum of: 1 year of experience with conducting comprehensive document reviews, including manufacturing batch records, quality control methods, protocols, reports, and validation documents; 1 year of experience with review and approval of method validation and technology transfer documents in compliance with ICH and FDA guidance; 1 year of experience with review of logbooks, QA batch disposition, and QA support; 1 year of experience with supporting QA for contract manufacturing organizations; 1 year of experience with reviewing and supporting QA equipment validation documents, installation qualification, operational qualification, performance qualification, and the maintenance and calibration of equipment. Up to 10% domestic and international travel required. #LI-DNI

Job location: Indianapolis, IN.

To apply, please visit https://jobsearch.lilly.com/ and enter job requisition number R-107946 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to: Eli Lilly and Company, Lilly Corporate Center, Drop Code 1093, Indianapolis, IN 46285.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.


Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.


Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).


Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$155,126.00 - $178,394.90 per year

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

Skills Required

  • Bachelor's degree in Pharmacy, Chemistry, Life Sciences, Engineering, or related field
  • 4 years experience with quality assurance and control in a pharmaceutical setting
  • 1 year conducting comprehensive document reviews (manufacturing batch records, QC methods, protocols, reports, validation documents)
  • 1 year reviewing and approving method validation and technology transfer documents in compliance with ICH and FDA guidance
  • 1 year reviewing logbooks, QA batch disposition, and providing QA support
  • 1 year supporting QA for contract manufacturing organizations (CMOs)
  • 1 year reviewing and supporting QA equipment validation documents, including installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and equipment maintenance and calibration
  • Ability to perform audits, lab walkthroughs, assessments of quality documentation and data, and QA review of GMP documentation to ensure compliance
  • Willingness to travel domestically and internationally up to 10%

Eli Lilly and Company Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Eli Lilly and Company and has not been reviewed or approved by Eli Lilly and Company.

  • Retirement Support Feedback suggests long-term savings are bolstered by a defined-benefit pension alongside a company 401(k) match and retiree health options. These elements make total compensation feel strong beyond base salary.
  • Leave & Time Off Breadth Feedback suggests paid time off is expansive, with substantial vacation, company shutdown days, and milestone time. This breadth of leave is viewed as a meaningful part of overall rewards.
  • Parental & Family Support Feedback suggests family-building and caregiving support are robust, including paid parental leave, adoption or surrogacy assistance, and backup care. These programs enhance the perceived value of benefits across life stages.

Eli Lilly and Company Insights

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The Company
HQ: Indianapolis, IN
39,451 Employees
Year Founded: 1876

What We Do

Eli Lilly and Company engages in the discovery, development, manufacture, and sale of products in pharmaceutical products business segment. For more than a century, we have stayed true to a core set of values – excellence, integrity, and respect for people – that guide us in all we do: discovering medicines that meet real needs, improving the understanding and management of disease, and giving back to communities through philanthropy and volunteerism.

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