Project Analyst I, Biocompatibility

Becton Dickinson Medical Devices•Durham, NC

20d•Onsite

About The Position

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 Corporate Preclinical Development and Toxicology (CPDT) 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 for medical devices.

Requirements

Minimum requirements: Bachelor’s Degree.
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, Outlook, and Access and have intermediate skills in MS Excel.

Nice To Haves

Other preferred software: SharePoint, LIMS systems, and DocuSign.

Responsibilities

Work with worldwide Toxicologists (Sponsors) to understand a project’s requirements if testing is deemed necessary.
Determine and communicate results and deadlines to business unit core project teams to ensure accurate expectation setting/planning.
Request required documentation, define sample types and sample size requirements, and provide expected completion dates for deliverables.
In cases of expedited requests, partner with team group managers to determine accelerated timeline/strategy.
Receive and record shipments, create inventory documentation (Master Inventory logs, labels, etc).
Manage test sample inventory by documenting chain of custody and aliquot to appropriate personnel as needed.
Generate Statement of Work contracts.
Collaborate with toxicologists and group leaders to ensure test plans are developed to meet project goals.
Create, organize, and maintain hard copy testing project files and electronic database.
Generate quotes for projects and update the quote tracking database.
Create Surface Area Records to be used in study conduct. This requires labelling of photos and/or manually calculating surface areas of components.
Perform aseptic prep as needed to allocated sterile test articles.
Monitor progress of multiple projects that are upcoming and ongoing.
Provide customers, Sponsors, and internal management with progress reports/status updates.
Promptly identify issues or delays and work with affected personnel to find resolutions.
Communicate any changes in strategy or timelines.
Promptly communicate all applicable reports and results to the customer, sponsor, and appropriate internal personnel.
Conduct review of project folders to ensure all deliverables have been communicated and project goals have been met.