As a Specialist Stability you will provide support to the Product Quality (PQ) organization as a subject matter expert of clinical and commercial product stability studies and GMP data management. In this team-based role, you will directly add to the success of a Product Quality Team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Regulatory, Quality Assurance, Quality Engineering, International Quality and Process Development on projects, issue resolution and investigations.
The Specialist Stability builds and monitors stability studies within quality systems (e.g. LIMS), owns and handles product quality and stability data and may serve as a primary author on regulatory filings and directly participate in and support site-based GMP inspections.
Additional responsibilities include business process support, such as SOP authoring and management, or gap assessments to regional regulations. Expertise in project management, time management and successfully navigation skills for matrix ed team environments are essential.
Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines.
Many of the technologies we’re employing are not only new to Amgen but are new to the industry as a whole.
Help us to pave new roads for helping patients.
Key Responsibilities include:
Build and maintain technical GMP documents and product stability studies
Review, verify, report, and archive GMP data for clinical and commercial products
Apply keen attention to detail to conduct data review and reports
Execute transactions in relevant GMP computer-based systems (change control, LIMS, etc.)
BasicQualifications Doctorate degree, or Master’s degree & 3 years of Quality, Operations, Scientific, or Manufacturing experience, or Bachelor’s degree & 5 years of Quality, Operations, Scientific, or Manufacturing experience
B.S. or advance degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with growing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment
Experience working in a regulated environment (either direct GMP or technical support)
Strong project management skills
Understanding of biologic and synthetic pharmaceutical bulk and drug product manufacturing and analytical techniques
General knowledge of cGMP and US and international filing regulations pertaining to the manufacture and testing of pharmaceuticals and/or bio-pharmaceuticals
Experience working on a cross-functional team in a matrix environment
Excellent written and verbal communication skills, including facilitation and presentation skills
"This posting is for Contingent Worker, not an FTE"