QA Floor Representative- Days

Eli Lilly and Company; Indiana (PA); On-site; USD 63,000 - 163,000; Full time

Job summary

A leading healthcare company seeks a QA Floor Representative to oversee quality assurance processes. This role involves mentoring staff, ensuring compliance with GMP standards, and supporting regulatory inspections. Ideal candidates will have a STEM degree and strong attention to detail. The position offers competitive compensation and benefits.

Benefits

Medical, Dental, Vision, Prescription benefits

Paid vacation starting at 120 hours annually

Eligible for annual bonuses

Shift differential

Qualifications

• Experience in GMP production environments or QCL.
• Proven track record of working independently or as part of a team.

Responsibilities

• Provide daily oversight and mentorship on quality matters.
• Ensure compliance with GMP programs and quality systems.
• Engage in Six Sigma Projects to improve efficiency.

Skills

Attention to Detail

Technical Writing

Communication

Problem Solving

Education

Bachelors Degree in STEM field

Tools

Microsoft Office

Regulus

TrackWise

PMX

SAP

Job description

QA Floor Representative- Days page is loaded

QA Floor Representative- Days

Apply locations US, Indianapolis IN time type Full time posted on Posted 2 Days Ago job requisition id R-85544

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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Responsibilities:

The QA Representative for the Floor Support team member provides daily oversight, assistance, and mentorship to issues such as non-conformance investigations, change control proposals, procedure / master formula revisions, validations, batch disposition, commissioning, and qualification activities. This position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies.

Benefits Overview:

• Medical, Dental, Vision, Prescription benefits are effective on your first day of employment
• Paid vacation- starting annually at 120 hours (prorated based on start date)
• Eligible for annual bonuses
• Shift differential

Key Objectives:

• Lead, mentor, and coach operations and support personnel on quality matters
• Ensure regular presence in operational areas to supervise GMP programs and quality systems
• Ability to assess and triage deviations / observations
• Work with Lilly support groups and external partners to resolve or provide advice on product related issues
• Take part in self-led inspections and provide support during internal / external regulatory inspections
• Engage in Six Sigma Projects to improve efficiency within the local process team or quality organization
• Support project and process improvement initiatives for Plant Process Teams as representative of the Quality function
• Approve commissioning qualification / validation documents for computer systems and equipment to ensure compliance with quality standards
• Network with Global Parenteral Network sites as resources and benchmarking sources as applicable flexibility within job assignment

Basic Qualifications:

• Bachelors Degree in STEM field

Additional Skills/Preferences:

• Proven track record of working independently or as part of a team to resolve an issue
• Strong attention to detail
• Experience in GMP production environments or QCL
• Previous experience with Lilly Event and Change Management processes
• Proficiency with computer systems including Microsoft Office products, Regulus, TrackWise, PMX, and SAP
• Demonstrate knowledge and understanding of manufacturing process
• Demonstrate technical writing and communication skills

Additional Information:

• This is a 12 hour shift role on a 3-2-2-3 rotating schedule
• Overtime may be required.
• May need to respond to operational issues outside of core business hours / days.
• 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

$63,000 - $162,800

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

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