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Quality Assurance Floor Support Specialist

3 months ago

Durham, North Carolina, United States Eli Lilly and Company 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.

Lilly is a new state of the art Parenteral, Device Assembly, and Packaging Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to be part of the Lilly team working in a state-of-the-art parenteral facility using isolator technology and a fully automated visual inspection.

The Quality Assurance Floor Support Specialist works as a member of the QA Floor Support team and reports to the QA Parenteral Associate Director. Responsibilities include performing AQL inspections, final classification of defects, sample management as well as providing QA oversight to GMP operations in the Parenteral visual inspection areas which includes automated visual inspection, semi- automated inspection, and manual inspection. QA Floor Support Specialist oversees visual inspection production functions to achieve patient safety and site goals through effective quality oversight.


Responsibilities:

Ensures regular presence in assigned parenteral areas to perform AQL inspections, manage sample collection/deliver to laboratories. Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals.Responsible for ensuring training is completed and remains in compliance.Communicates with QA Representative and QA Parenteral Associate Director on quality and operational issues.Ensures adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel.Advise Operations and support personnel on quality matters, while driving the site Quality culture.Reviews and approves GMP documentation in support of daily operations such as: electronic batch record logs, paper logbooks, cleaning, and procedures versus performance. Provide QA systems support to reconcile issues in systems; such as, inventory control systems (SAP), laboratory LIMS system (Darwin) and other systems as required (TrackWise, PMX).Participate in self-led inspections and provide support during internal / external regulatory inspections.
Basic Requirements:High School Diploma or equivalentDemonstrated experience in GMP facilityQualified 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.Must pass a vision exam and be free of color blindnessMust be equivalent to 20/20 correctable close vision acuityAdditional Skills/Preferences:Parenteral Inspection experience (automated, semi-automated and manual).Associate degree in a science, engineering, computer, or pharmaceutical related field of study, preferred.Strong understanding of quality systems in the inspection environment.Demonstrated strong oral and written communication and interpersonal skills to communicate to operators and management.Demonstrated knowledge and understanding of pharmaceutical process and Quality Systems.Strong attention to detail and demonstrated organizational skills.Basic computer skills including Microsoft Office products, (Excel, Word, PowerPoint, Outlook), inventory control (SAP), and electronic batch records (PMX)Ability to work cross functionally and work collaboratively with all levels of the organization.Proven ability to work independently or as part of a team to resolve issues.
Additional Information:Shift Monday - Thursday or Tuesday - Friday, 10 Hours (Day Shift)Ability to work overtime, as requested.Ability to wear safety equipment (safety glasses, safety shoes, protective gloves, etc.) and follow site gowning requirements.Physical Demands: Light work that requires physical effort. Requires good communication skills, eye-hand coordination and manual skills. Occasionally requires force to raise, to load, and to push objects. Occasionally requires movements of the body like to incline, to climb, to kneel, to bend, to rise, and to walk down stairs.Must pass an annual vision test and be free of color blindness.Must be equivalent to 20/20 correctable close vision acuity 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 ( ) 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. #WeAreLilly