Principal Associate - QA Incoming Batch Disposition

Job Details
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 Incoming 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 disposition of incoming materials, components, and raw materials. Will 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 Incoming Batch Disposition process to ensure material released for use meets applicable GMP standards.
Key Objectives/Deliverables

• Performs batch disposition of raw materials, components, active pharmaceutical ingredient (API), and consumables to ensure high quality medicine (GMP Compliance) is released within expected metrics to ensure timely release to market.
• Lead, mentor and coach site personnel on quality matters associated with the batch or batch disposition process.
• 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 Six Sigma project or process improvement initiatives to improve productivity within the Incoming Batch Disposition work center and/or the site.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Minimum Qualifications

• Bachelors or equivalent (Science or Engineering related degree preferred).
• At least 10 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 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 this employment position.

Additional Preferences/Skills

• Proficiency with Manufacturing Execution Systems (PMX or similar), Inventory Management Systems (SAP or similar), Laboratory Information Management System (LIMS; such as, Darwin or similar), Deviation Management Systems (TrackWise).
• Demonstrated relevant experience in a GMP facility.
• Ability to make technical decisions, provide guidance to the site and lead others.
• Demonstrated strong oral and written communication skills.
• Demonstrated interpersonal skills and the ability to work as a team.
• Demonstrated attention to detail and ability to maintain quality systems.
• Previous regulatory inspection readiness and inspection execution experience.
• Ability to work overtime as required.
• CQA certification from the American Society for Quality (ASQ)

Additional Information:

• Position is day shift and includes the requirement to work rotating weekends.
• Proven ability to work independently or as part of a Team to resolve an issue.
• Ability to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations.
• The position is for the Lilly Research Triangle Park site and will allow for a flexible working environment with the ability to periodically work remotely based on site activities.

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 ( ) 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
$63,000 - $162,800
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
Company
Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to "take what you find here and make it better and better." More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit.
Company info
Location 893 S Delaware St
Indianapolis
Indiana
46285
United States
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