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QA Representative Batch Disposition

3 months ago

Concord NC United States Lilly Full time

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.

Organization Overview:
Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site.  The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don’t want to miss

What You'll Be Doing:
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 QA Batch Disposition is responsible final disposition of Semi-Finished and/or Finished drug combination products. The QA position is essential for ensuring GMP compliance in the qualification, validation, control strategy and startup of operations to ensure regulatory approval of the facility. Electronic batch records with high integration and focus on data integrity will be utilized to confirm manufacturing production. 

Key Objectives/Deliverables:

·       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 

·       Performs final batch disposition of semi-finished and/or finished drug product and combination 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.: Deviations, procedures, protocols, specifications, and change controls) 


Basic Requirements:

·       Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent experience  

·       Experience working in the pharmaceutical or medical device industry in QA roles 

·       Previous batch disposition experience 

Additional Skills/Preferences:

·       Proficiency with SAP, MES, and Trackwise

·       Root cause analysis/troubleshooting skills 

·       Previous regulatory inspection readiness and inspection execution experience 

·       Previous experience with Event and Change Management process

·       Previous experience with device and parenteral product materials 

·       Previous experience with applicable computer systems 

Additional Information:

·       Ability to work 8-hour days – Monday through Friday Day Shift (not eligible for remote work)

·       Ability to travel up to 10% for meetings and coordination with global or existing manufacturing sites 

·       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 R1-R4.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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