Project Analyst I, Biocompatibility

Job Description Summary Job Description We are the makers of possible    BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.    We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.  As part of The Project Management Office of the Corporate Preclinical Development and Toxicology (CPDT) department, the Biocompatibility Project Analyst will support the conduct of nonclinical laboratory investigations of medical devices and materials in accordance with GLP and ISO 17025 regulations and the BD CPDT Quality System. Project Analyst provides operational support for preclinical testing projects to facilitate workflow, receive and manage test sample inventory, monitor deliverables, coordinate testing activities, provide client support, and assist with preparation of final documentation packages in a corporate group that performs biocompatibility and chemical testing as required by FDA and other international regulatory agencies for medical devices. Education and Requirements: Minimum requirements: Associate's degree; Bachelor’s degree preferred. Understanding of GLP or GMP quality system, ISO 10993, ISO 17025, and other international medical device standards. Experience with project management. Able to handle multiple priorities to ensure project completion in a multi-tasking deadline driven environment. Outstanding written and oral communication skills Strong customer service and client facing ability Excellent attention to detail Excellent time management and organizational skills Ability to think critically to find solutions to complex problems Ability to work well within a matrixed organization in order to influence without direct authority Must be proficient with MS Word and Outlook.. Basic/Intermediate skills in MS Excel. Other preferred software: SharePoint, LIMS, Teamcenter, and DocuSign. Responsibilities: Planning Work with Project Managers to understand a project’s requirements if testing is deemed necessary. Identify discrepancies and missing information when reviewing project documentation during project set-up. Initiation Receive and record shipments, create inventory documentation (Master Inventory logs, labels, etc). Manage test sample inventory by documenting chain of custody and allocate to appropriate personnel as needed. Generate Statement of Work contracts and Surface Area Records. Collaborate with Project Managers, toxicologists, and group leaders to ensure test plans are developed to meet project goals. Create, organize, and maintain hard copy and electronic testing project files and update electronic databases. Request quotes for projects, share with teams, and request Business Unit approvals. Study Involvement Create Surface Area Records to be used in study conduct. This requires labelling of photos to ensure the lab understands each component on a device. Perform aseptic prep as needed to allocate sterile test articles. Promptly identify issues or delays and work with affected Project Managers to find resolutions. Conduct review of project folders to ensure all deliverables have been communicated and project goals have been met. Ship or discard unused samples and submit the project for Closure Review and Archive storage. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.   To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.   To learn more about BD visit https://bd.com/careers  Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work Location USA NC - Durham - Davis Drive Additional Locations Work Shift US BD 1st Shift 8am-5pm (United States of America)