תיאור המשרה
This role is a fixed term position - 6 months to 1 year for a maternity leave coverage. Could turn into a FT position. Hybrid 3 days in office, 2 days remote. At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. Job Summary In this hybrid fixed term role (2 days remote, 3 days in office), you will be part of the Materials & Biological Safety ( MBS) team, responsible for creating and maintaining material data and biological safety information, for medical devices manufactured by West Pharmaceutical services Inc. as Materials & Biological Safety Associate Specialist. You will be responsible for providing ongoing material and biological safety support for R&D and Engineering teams and regulatory submissions. Essential Duties and Responsibilities Local/site point of contact for internal employees, external clients and service providers regarding materials and biological safety of West Medical Devices platforms mainly VTD and V2B. Support the design and development teams with materials research, evaluation, and selection. Liaise with Product Design, Validation & Verification and Project Managers/Leads to achieve project goals through high quality, accurate and timely completion of deliverables. Responsible for directing external/third-party biocompatibility testing service providers and coordinate testing at external labs. Coordinate, build and procure sample devices from the manufacturing plant for use in biocompatibility and/or chemical characterization evaluations. Create (author) and/or review and approve biocompatibility test plans, protocols, and reports. Create (author) and/or review and approve biological gap assessments for Medical Devices and manufacturing process.
