Eli Lilly

QA Batch Disposition

Eli Lilly$65K — $169K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a science, engineering, computer, or pharmaceutical field.
  • 2+ years of batch disposition experience in device, parenteral, or drug substance products.
  • Authorized to work in the U.S. without sponsorship.
  • Relevant experience in a GMP facility.
  • Experience in QA roles in the pharmaceutical or medical device industry.

Responsibilities

  • Perform batch records review for various processes including formulation and visual inspection.
  • Conduct final batch disposition to ensure timely market release of high-quality medicine.
  • Review and approve GMP documents for compliance with quality attributes.
  • Support site readiness and development of e-release processes for new systems.

Benefits

  • Company-sponsored 401(k) and pension plans.
  • Vacation benefits and eligibility for medical, dental, vision, and prescription drug coverage.
  • Flexible spending accounts for healthcare and dependent care.
  • Life insurance and death benefits.
  • Comprehensive well-being benefits including employee assistance programs and fitness initiatives.
Full Job Description
Position Description:

The Quality Assurance Representative has oversight for the disposition of incoming materials, components, final disposition of semi-finished products. As the authorized quality representative, serve as a technical leader within Quality to ensure proper adherence to Global and Local Quality requirements and ensure that there are adequate quality systems in place related to the Batch Disposition process to ensure product released to the market meets applicable GMP standards. This role is essential for ensuring GMP compliance in the qualification, validation, control strategy and startup of operations to ensure regulatory approval of the facility.

Responsibilities:
  • Performs batch records review for Component Preparation, Formulation, Filling, Visual Inspection, Environment Monitoring and audit trail review of semi-finished batches
  • Performs final batch disposition of semi-finished product batches, to ensure high quality medicine (GMP Compliance) is released to market in a timely manner
  • Effectively review/approve GMP documents to ensure quality attributes are met (i.e.: non-conformances, procedures, protocols, specifications, and change controls)
  • Support the site in the development and execution of the site readiness plan with focus on supporting development of the site e-release process and startup of new systems


Basic Requirements:
  • Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study.
  • 2+ years previous batch disposition experience supporting device, parenteral or drug substance products/materials.
  • 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.


Additional Skills/Preferences:
  • Demonstrated relevant experience in a GMP facility
  • Experience working in the pharmaceutical or medical device industry in QA roles
  • Previous batch review and disposition experience
  • Ability to make technical decisions, provide guidance to the site
  • Proficiency with applicable computer systems (MasterControl, SAP, Darwin)
  • Demonstrated strong oral and written communication skills
  • Demonstrated interpersonal skills and the ability to work as a team
  • Root cause analysis/troubleshooting skills
  • Demonstrated attention to detail and ability to maintain quality systems
  • Previous regulatory inspection readiness and inspection execution experience
  • Ability to travel up to 10% for meetings and coordination with global or existing manufacturing sites.
  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals


Additional Information:
  • Day shift
  • Proven ability to work independently or as part of a Team to resolve an issue


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
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ

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