R&D Analytical Quality Assurance Representative

Eli Lilly and Company • Us, IN

2d • $65,250 - $148,500 • Onsite

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. The R&D Quality Assurance Analytical Representative ensures continued organizational alignment with the business strategy and that laboratory activities conducted by R&D laboratories and Collaboration Partners (CPs) are carried out in accordance with R&D quality standards and/or are following current Good Manufacturing Practice (cGMP). This role is responsible for assuring the laboratory maintains a state of control with regards to the generation and reporting of analytical data. Primary loop responsibilities for the oversight of analytical data generated to support GMP operations for R&D are required.

Requirements

• 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.

Nice To Haves

• Experience in Quality Assurance/Control, Technical Services, Laboratory, Development, or Manufacturing desirable.

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.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level