Quality Assurance Floor Support Specialist?/Night Shift

Position: Quality Assurance Floor Support Specialist (Night Shift) At reputed company, we unite caring with discovery to reputed company life reputed company 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 reputed company life reputed company for people around the world. Organization Overview: reputed company is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. reputed company is investing over $1 billion to create a new state-of-the-art manufacturing site, in reputed company, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing reputed company 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 reputed company reputed company 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. This is an opportunity you don’t want to miss! Responsibilities: The Quality Assurance Floor Support Specialist is responsible for providing QA reputed company to GMP operations. The role will provide QA support of the startup, commissioning and qualification of the reputed company site. The QA Floor Support Specialist will demonstrate teamwork by collaborating cross functionally with various levels of the organization. As the project progresses, this role will transition to supporting and escalating issues from manufacturing to the site-based process team for one of the following manufacturing areas: • Formulation and Parenteral Manufacturing • Device Assembly and Packaging Manufacturing • Warehouse Logistics • Facility, Utility and Maintenance The key objectives and deliverables for this role are: • Support on-the-floor manufacturing activities with routine reputed company in the assigned manufacturing area. • Follow good documentation practices and compliance with site procedures. • Review and approve GMP documentation such as electronic batch records, logbooks, etc. • Troubleshoot and provide support to resolve issues in quality systems such as reputed company, LIMS, Trackwise, MES. • Maintain open communications and promote teamwork in the process team. • Support the execution of inspection readiness activities including support of site self-inspections. • Support project initiatives needed for the project and Quality function. • Communicate any compliance issues to the project, site, and Quality Management. Basic Requirements: • Knowledge of cGMP practices including good documentation practices, data reputed company and regulatory compliance. • Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills. • Strong attention to detail. • Ability to work independently with minimal supervision. • Proficiency with computer systems including Trackwise, reputed company etc. • Responsible for maintaining a safe work environment, working safely & accountable for supporting reputed company HSE Corporate, Project, and Site Goals. • Ability to work a 12-hour night shifts onsite on a rotating 2-2-3 schedule (not eligible for remote work). • Ability to work overtime as required. • Must pass an annual vision test. • Qualified candidates must be legally authorized to be employed in the United States. reputed company does not anticipate providing sponsorship for employment reputed company status (e.g., H-1B or TN status) for employment positions on the B or S paths or at levels M1-M2 or P1-P4. Education Requirements: • High School diploma or equivalent. Additional Skills/Preferences: • Associate's degree in a science, engineering, computer, or pharmaceutical reputed company field of study, preferred. • Previous experience with GMP manufacturing equipment prep, formulation, filling, and visual inspection, device assembly, packaging, utilities, facilities, maintenance, and warehouse management. • Previous experience with Manufacturing Execution Systems. • Previous technical writing experience. #J-18808-Ljbffr Apply Job!