Eli Lilly

Quality Assurance Process Team Device Assembly and Packaging

Eli Lilly • $65K — $169K *
Concord, NC 28027In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific field.
  • 4+ years in Quality pharmaceutical manufacturing.
  • Experience with C&Q / Verification and Validation oversight.
  • Knowledge of US, EU, Japan regulations in pharmaceutical manufacturing.
  • Strong communication skills with cross-functional teams.
  • Ability to work independently as a Quality Subject Matter Expert (SME).
  • Proficient with SAP, Trackwise, and MES.

Responsibilities

  • Maintain an active presence in operational areas to ensure quality standards.
  • Oversee verification and qualification of manufacturing equipment and buildings.
  • Guide and resolve deviations and change controls in quality processes.
  • Understand and communicate processes, equipment, and operations comprehensively.
  • Establish and lead annual quality floor time planning.
  • Support resolution of batch documentation issues.
  • Lead continuous improvement initiatives and measure quality metrics.

Benefits

  • Company-sponsored 401(k) and pension plan.
  • Medical, dental, vision, and prescription drug benefits.
  • Flexible spending accounts for healthcare and dependent care.
  • Life insurance and death benefits.
  • Well-being programs including employee assistance and fitness benefits.
Full Job Description
Responsibilities:

The Quality Assurance Process team member is responsible for demonstrating leadership, teamwork, and quality knowledge on a day to day basis. They are responsible to lead, mentor, and coach operations and support personnel on quality matters. They will provide support on deviations, change controls, procedure updates, commissioning, and qualification activities. This role will have a regular presence in the operational areas to monitor and confirm execution according to quality standards.

This role will participate on the local process team for one of following manufacturing areas:
  • Device Assembly
  • Packaging
  • Project Focus for DAP


Responsibilities include:
  • Active presence in operational areas
  • Provide quality oversight for the verification and qualification of the manufacturing equipment, buildings, including review of test cases, test execution, discrepancy resolution, etc.
  • Provides guidance for leveling, resolving, reviewing and approving deviations and change controls
  • Demonstrate a comprehensive understanding of the process and its associated equipment, facilities, computer systems and operations
  • Lead and establish annual quality floor time plan
  • Support resolution of batch documentation such as alarm response, exceptions, etc
  • Support asset qualification monitoring reviews and reports
  • Required to respond to operational issues outside of core business hours / days.
  • Attend and provide update on quality at daily process team meeting
  • Support the site organization in building technical capability, in Quality, the project team, and area process teams, including mentoring and training of new Quality staff
  • Resolve or escalate any compliance issues to Quality Management
  • Identify and implement continuous improvements
  • Measure, maintain, and achieve quality metrics
  • Serve as positive role models for their Process Team peers and for the organization in general


Basic Requirements:
  • Bachelors or equivalent degree in a scientific field
  • 4+ years' experience in Quality pharmaceutical manufacturing required
  • Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation
  • Use process knowledge and control strategy to make quality decisions
  • Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing
  • Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills
  • Ability to work independently as a Quality SME with minimal supervision
  • Proficiency with computer systems including SAP, Trackwise, MES etc.
  • Responsible for maintaining a safe work environment,
  • Ability to work 8 hour shifts onsite (not eligible for remote work)
  • Ability to work overtime as required
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the B or S paths or at levels M1-M2 or P1-P4.


Additional Skills/Preferences:
  • ASQ Certified
  • CSQA experience
  • Previous experience with device assembly or packaging,
  • Previous experience with Manufacturing Execution Systems.
  • Previous use of KNEAT - or other electronic validation software
  • Previous technical writing experience


Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400

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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