QA Primary Loop

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.

Responsibilities:

• 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.

Basic Requirements:

• 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

Additional Skills/Preferences:

• 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

Additional Information:

• Travel: Less than 10%
• Shift information: Day shift Monday-Friday. May be required to respond to operational issues outside of core business hours / days.
• Overtime may be required
• Position location: LTC-South
• Applicant may work in various areas within the Parenteral Plant.  Some allergens are present in the Parenteral Plant.  Mobility requirements and exposure to allergens should be considered when applying for this position.
• May be subject to Post Offer Exam

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$66,000 - $116,600

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.

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