Lilly CAPA Team Specialist in Research Triangle Park, North Carolina
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.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
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.
This position is for a CAPA Team Specialist. CAPA Team specialists will be responsible working with team members to understand human factors in the process, review process data, and identify improvements to processes and manufacturing practices in the production and warehouse spaces. The CAPA team specialist will contribute to a positive quality culture at the Lilly RTP site by working collaboratively with shop floor personnel and support teams to identify root cause for deviations and improve process robustness. CAPA team specialists will also assist the operations team in the day to day management of the production floor and lead investigations and drive implementation of actions associated with deviations.
Provides on-the-floor support working cross functionally with operations and warehouse team members, quality assurance, and safety to respond to events.
Participates and/or lead cross functional teams in the development and implementation of strategies associated with the area for the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE).
Trained as a Lead Investigator
Executes GEMBA activities with shop floor personnel to understand root cause and corrective actions for quality and safety events.
Compiles, reviews and analyzes production data, deviation and safety trends
Executes corrective and preventative actions, including improvements to production practices and procedures.
Authors and executes protocols for response and remediation of events.
Presents as a subject matter expert and supports regulatory inspections.
Supports continuous improvement efforts within the operations and warehouse areas.
Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Goals.
Bachelor’s degree (or equivalent work experience in GMP production)
Experience in technical writing, data analysis, and presentation of data.
Understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA.
Familiarity with root cause analysis tools such as 5 Whys, causal factor analysis, tree diagrams, fishbone diagrams
Experience with electronic batch records such as Pas-X, Syncade, or PMX
Experience with supporting automated equipment and use of data tools such as OSI PI, Power BI, Tableau
Experience interacting with and presenting as a subject matter expert to regulatory agencies
Device Assembly, Packaging, or GMP Warehouse experience
Engineering or Science degree preferred
- Bachelors degree (or equivalent work experience in GMP production)
The position is for the Lilly Research Triangle Park site and will require on site presence with the ability to periodically work remotely based on the project phase and site activities.
Must be flexible to attend meetings or support off-shifts on occasion.
The job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).