Job Description

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.

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

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 primary responsibilities of the QA Engineer are to assure compliance with corporate quality systems and current GMPs for the Operations of IDAP. This position provides quality oversight of the Production Quality System in support of operations, including assistance and mentorship in the execution of change controls, equipment qualification, process validation, computer system quality, deviations, and complaint investigations. This assignment will involve a high level of engagement with Operations, Engineering, and area Leadership.

Promote safety awareness
Remain current with individual training plan
Observe, promote, and follow requirements related to safety, quality, security, customer service, and GMPs
Provide consultation and interpretation of quality guidance documents regarding qualification / validation, cleaning, change control, production practices, deviations, CSQ, and complaint management
Provide quality oversight and provide quality support for bringing new products into IDAP
Provide quality oversight of the IDAP operations and processes to support QA Floor Reps / QA Technicians floor decisions
Raise notification to management for departures of critical nature and assure issues are addressed
Assess gaps between local and corporate standards and facilitate remediation efforts actively working with support areas
Ensure area is always audit ready
Support project timelines assuring compliance with Quality expectations
Proactively work with areas to provide support and promote consistency with Quality expectations and discuss resolution with process team members
Possess a detailed understanding of the IDAP processes including critical parameters, components used, equipment, etc.
Actively assist in continuous improvements and efficiency projects
Provide quality impact assessments, reviews and approvals on validation protocols, qualification documents, change controls, deviations, holds, procedures, and maintenance work orders related to the IDAP processes
Actively seek expanded knowledge of applicable technologies, processes, and regulations through training, networking, floor presence, and project participation
Provide leadership in communicating cGMP requirements to shop floor and promote best practices through direct contact with production, maintenance, engineering, and automation

Basic Qualifications:

Bachelor's Degree (STEM related degree preferred) or equivalent experience

Additional Skills/Preferences:

3 or more years' experience in a GMP environment preferred
Previous experience in Quality Assurance or Engineering preferred
Knowledge of cGMPs, Production Processes, Quality Systems, and FDA regulations
Experience supporting computer systems (e.g. CSV, CSQ, IDS experience)
Proficiency with computer systems such as TrackWise, SAP, PMX, and Quality Docs
Experience in conducting root cause investigations, and execution of change management, equipment qualification, and process validation
Ability to communicate effectively with customers to carry out requirements
Ability to work under time pressure, exert good judgment in special situations, make decisions independently under minimum supervision, and problem solve
Ability to influence team interactions and lead initiatives
Demonstrated strong oral and written communication and interpersonal skills
Demonstrated decision making and problem-solving skills
Demonstrated knowledge and understanding of manufacturing process and Quality Systems
Demonstrated attention to detail
Demonstrated ability to coordinate and prioritize multiple tasks.

Additional Information:

Flexibility is required as work hours and start times may vary to provide coverage on different shifts to meet business needs
Overtime and weekend work may be required.
Individual must be available via cell phone (on-call)
Applicant may work in various areas within the IDAP Plant. Some allergens are present in the IDAP Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
Some travel may be required

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

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 and Company

Learn More About Eli Lilly and Company

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.

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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.

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Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.

Total value of jobs:

$388,184,974

Total Jobs:

407

Average Pay:

$140,138

% Masters:

48%

* Ladders Estimates