QA Batch Disposition

Location Type: On-site

 

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.

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.

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
$63,000 – $162,800

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.

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.

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