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 Brand Description:
The Quality Assurance Batch Disposition team assures patients worldwide of safe and efficacious drug and device products, through effective quality oversight of site activities. The Quality Assurance Representative has oversight for the final disposition of semi-finished and/or finished drug combination products and packaging products including vials and dry. 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 is adequate quality systems in place related to the Batch Disposition process to ensure product released to the market meets applicable GMP standards.
Key Objectives / Deliverables:
- Performs batch disposition of incoming materials, semi-finished and/or finished drug product batches for Indianapolis Device Assembly and Packaging, including commercial and clinical trial materials to ensure high quality medicine (GMP Compliance) is released to market in a timely manner.
- Lead, Mentor and Coach Operation and support personnel on quality matters associated with the Batch / Batch Disposition.
- Provides guidance in operational areas to ensure robust Quality Systems and GMP compliance.
- Participate in self-led inspections and/or provide support during internal / external regulatory inspections.
- Effectively review / approve GMP documents to ensure quality attributes are met (i.e. Non-conformances, procedures, protocols, specifications, and change controls).
- Participates in project or process improvement initiatives to improve productivity within the Batch Disposition work center and/or the site.
Minimum Requirements:
- Bachelor's Degree (Science or Engineering related degree preferred)
- At least 5 years working in the pharmaceutical or medical device industry in QA roles.
- 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 Preferences:
Proficiency with applicable computer systems.
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.
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
Proven ability to work independently or as part of a team to resolve an issue.
Previous experience with Lilly Event and Change Management process.
Proficiency with SAP, MES (PMX, Pharma Suite), and Darwin.
Previous experience in GMP QA is desirable.
Technical Writing and Communication Skills.
Education Requirements:
- Bachelor's Degree (Science or Engineering related degree preferred)
**Other Information: **
- Overtime may be required.
- May be required to respond to operational issues outside of core business hours / days.
- Rotating On-Call during the weekend
- 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.
- Position is located at the Lilly Technology Center – South.
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.
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