Eli Lilly

QA Representative - Warehouse

Eli Lilly • $65K — $148K *
Research Triangle Park, NC 27709In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in science, engineering, computer, or pharmaceutical field preferred.
  • Minimum of 2 years of quality experience in the medical device or pharmaceutical industry.
  • Authorization to work in the U.S. without the need for visa sponsorship.
  • Experience with GMP production environments is preferred.
  • Familiarity with automated warehouse systems like ASRS and AGV is beneficial.

Responsibilities

  • Adhere to and promote safety regulations in the warehouse environment.
  • Mentor and coach staff on quality assurance practices.
  • Conduct regular monitoring of GMP compliance in warehousing and logistics areas.
  • Engage in cross-functional teams to address supply chain and logistics quality issues.
  • Support third-party warehousing compliance related to RTP materials.
  • Triage deviations and service provider issues in warehouse operations.
  • Prepare documentation and provide quality oversight for internal and external audits.

Benefits

  • Eligibility for a company-sponsored 401(k) and pension plan.
  • Comprehensive medical, dental, and vision benefits.
  • Generous vacation benefits and time off policies.
  • Access to flexible spending accounts for healthcare and dependent care.
  • Employee assistance programs and fitness benefits.
Full Job Description
Site Overview:

The Lilly RTP warehouse is a fully automated warehouse system with automated pallet conveyors, pallet exchangers, ASRS (Automated storage and retrieval system), and AGV (Autonomous Guided Vehicle) delivery of materials to the line. The Quality Assurance Representative for the Warehouse and Logistics teams provide daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedures revisions, validations, batch disposition, commissioning, and qualification activities, with a focus on Automated Warehouse operations. This role reports directly to the Sr. Manager- QA Materials and Logistics. The Quality Assurance Representative position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval/General Inspections by various regulatory agencies.

Key Objectives/Deliverables:
  • Responsible for adhering to safety rules and maintaining a safe work environment for both self and others by supporting safety corporate and site goals.
  • Lead, mentor, and coach operations and support personnel on quality matters.
  • Ensure regular presence in warehousing areas, while also supporting device assembly and packaging areas, to monitor GMP programs, and quality systems.
  • Active on local cross-functional teams with focus on Warehousing. Logistics, 3rd party logistics and supply chain matters.
  • Provide quality support with third-party warehouse locations that maintain RTP materials.
  • Ability to assess and triage deviations, supplier or service provider issues that occur within the warehouse, logistics, supply chain or 3rd party logistics areas.
  • Work with Lilly support groups and external partners (including 3rd party logistics) to resolve or provide advice on receiving, shipping, storage or production supply issues.
  • Participate in self-led inspections and provide support during internal / external regulatory inspections.
  • Effectively review and / or redline to ensure quality attributes are met. (i.e, deviations, supplier complaints, procedures, technical studies, validation protocols, change controls, and engineering documents).
  • Approve commissioning qualification / validation documents for computer systems and equipment related to the warehousing operations, to ensure compliance with quality standards.
  • Participate in Six Sigma Projects focused on continuous improvement and productivity within the quality organization or cross-functional teams.

Basic Requirements:
  • Bachelor's degree - preferred in a science, engineering, computer, or pharmaceutical related field of study.
  • 2 years previous quality experience - supporting device, parenteral/drug substance products/materials, or medical device industry.
  • 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 or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.


Preferred Attributes Not Required:
  • Proficiency with computer systems including Microsoft office products, inventory management systems, and deviation management systems (i.e., SAP, Veeva, Trackwise, etc.)
  • Proven ability to work independently or as part of a team to troubleshoot and assess root cause.
  • Strong attention to detail.
  • Demonstrated strong oral, written and interpersonal communication skills.
  • Demonstrated decision making and problem-solving skills.
  • Previous experience in GMP production environments.
  • Demonstrate knowledge and understanding of manufacturing process and Quality Systems.
  • Previous experience in warehousing operations.
  • Previous experience with ASRS warehousing, Autonomous Guided Vehicles, and integrated systems.
  • Previous work with combination products or devices with experience with US/EU regulations and notified bodies.
  • CQE, or CQA certification from the American Society for Quality (ASQ)
  • Computer Systems Quality (CSQA) experience
  • Previous facility or area start up experience.


Additional Information:
  • Ability to work 8-hour days - Monday through Friday (Day Shift).
  • Ability to work overtime as needed and be on call as required.
  • Proven ability to work independently or as part of a Team to resolve an issue.
  • Applicant may work in various areas within the PAR, DAP and Warehouse buildings. Mobility requirements should be considered when applying for this position.
  • The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment with the ability to periodically work remotely based on the project phase and site activities.
  • Ability to travel up to 10% to 3PL Locations or Indianapolis, IN for meetings and coordination with global regulatory organizations required


Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $148,500

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

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ
LLY
* Ladders Estimates

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