Quality Representative - Concord, NC, United States - Lilly

Description

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.

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.

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.

• 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:
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
• Proficiency with applicable computer systems
• 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
• H-1B or TN status) for employment positions on the B or S paths or at levels M1-M2 or R1-R4.

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

• Proficiency with SAP, MES, and Trackwise
• Previous experience with device and parenteral product materials

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.

Please note This email address is intended for use only to request an accommodation as part of the application process.

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.

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.