QA Primary Loop

Eli Lilly and Company-posted 6 days ago

$66,000 - $116,600/Yr

Full-time • Mid Level

Onsite • Us, IN

5,001-10,000 employees

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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. Position Brand Description: The QA Representative - Floor Support team member provides daily oversight, assistance, and guidance to issues within Parenteral Visual Inspection such as deviation investigations, change control proposals, procedure / batch record revisions, validations, batch disposition, commissioning, and qualification activities. The QA Representative position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies.

Lead, mentor, and coach Operations and support personnel on quality matters.
Ensure regular presence in visual inspection operational areas to monitor GMP programs and quality systems.
Collaborate cross-functionally as a core member of a manufacturing process team.
Assess and triage deviations that occur within the local process team.
Work with Lilly support groups and external partners to resolve or provide advice on product related issues
Participate in self-led inspections and provide support during internal / external regulatory inspections.
Effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations, procedures, technical studies, validation protocols, change controls, and engineering documents)
Support project and process improvement initiatives for plant Process Teams.

Bachelor's degree or equivalent (Science or Engineering related degree preferred).
Strong oral and written communication and interpersonal skills
Demonstrated decision making and problem-solving skills
Technical writing skills

Previous experience in/with GMP production environments or Quality Control Laboratories
Knowledge and understanding of manufacturing processes and Quality Systems
Proven ability to work independently or as part of a team to resolve an issue
Strong attention to detail

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).

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