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.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$28.12 - $46.88The Quality Assurance Floor Support Team assures patients worldwide of safe and efficacious drug products, through effective quality oversight of Indianapolis Parenteral Operations activities.
The QA Floor Lead Tech is responsible for providing daily support and oversight to GMP operations in Raleigh-Durham North Carolina. The QA Floor Support Lead Tech works as a team member supporting multiple production functions (formulation, filling, and visual inspection), from operations to maintenance, to achieve site goals while providing Quality oversight and guidance.
Key Objectives/Deliverables:
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site GoalsProvides daily presence in operational areas to:monitor GMP programs and quality systems and ensure adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel.monitors for, retrieves, and completes review of all paperwork in need of quality review in each area supported and coordinates delivery to the associated area when complete.Supports visual inspection AQL inspection.Review and approve GMP documentation in support of daily operations such as:Cycle Summary Reports for equipmentElectronic batch record initiationDaily documentation of quality on the floor oversightMaintenance action plansReturn to Service and Release of equipment, product, and area HOLDsWork Order assessments and issue resolutionOther documents as requiredProvide guidance and assistance in identifying potential product quality impact and assessing if Observations are requiredPerforms observational requirements for Aseptic Process Simulation 14-Day Reads and supporting observation during formulation and fill related aseptic activities.Provide QA systems support to reconcile issues in multiple systems such as:SAP (inventory management)PMX (electronic batch record)TrackWise (complianceVeeva (controlled document repository)GMARS (calibration and maintenance system)And other systems as requiredWork within team to ensure all manufacturing areas receive QA support needed to maintain daily operationsReviews GMP documents (e.g., Procedures, Protocols, and Production Record Instructions)Requirements (Education, Experience, Training):
High school diploma or equivalentDemonstrated relevant pharmaceutical experience in aseptic manufacturingAssociates degree in a science, engineering, computer, or pharmaceutical related field of study, preferredStrong oral and written communication and interpersonal skillsStrong attention to detailExperience in Production QA, QC is desirableExperience in Visual Inspection is desirableExperience with TrackWise Deviation and Change Management processes
Additional Information:
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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