Lilly QA Batch Disposition in United States
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 35,000 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.
Lilly is a fortune 500 company in operation for over 140 years creating high-quality medicines for our patients while living our company values of Integrity, Excellence, and Respect for People in everything that we do.
Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.
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 (Authorized Quality Representative) is responsible for final disposition of Semi-Finished and/or Finished drug combination products. Additionally, AQRs 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.
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.
Lead, Mentor and Coach Site personnel on quality matters associated with the Batch / 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 Batch Disposition work center and/or the site.
At least 5 years working in the pharmaceutical or medical device industry in QA roles.
Previous batch disposition experience.
Ability to make technical decisions, provide guidance to the site and lead others
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.
Previous regulatory inspection readiness and inspection execution experience.
Ability to work overtime as required
Ability to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations.
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
Previous facility or area start up experience.
Proven ability to work independently or as part of a Team to resolve an issue
Previous experience with Event and Change Management process.
Proficiency with SAP, MES (PMX), and Darwin.
Previous experience with device and parenteral product materials.
CQA certification from the American Society for Quality (ASQ)
Previous experience with deviation and change management systems including Trackwise
Bachelors or equivalent (Science or Engineering related degree preferred).
Demonstrated relevant experience in a GMP facility
The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment will the ability to periodically work remotely based on the project phase and site activities.
Position may require a short duration assignment of 1-2 months in Indianapolis to establish specific device knowledge and establish global contacts.
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 ( LillyRecruitingCompliance@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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!