6 specialist quality assurance jobs found

We are currently looking to fill a Principal External Manufacturing Specialist role. The External Manufacturing Principal Specialist provides technical and process support for all aspects of clinical and commercial parenteral drug product operations in the External Manufacturing Network. Coordinates all aspects of manufacturing operations including oversee day-to-day operations, ensure timely completion of associated operations/documentation, and assist in the monitoring of cGMP compliance at drug product contract manufacturers.   As a Principal External Manufacturing Specialist, a typical day may include the following: Serve as the primary Regeneron technical contact for select DP contract manufacturing sites concerning day-to-day activities. Liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners. Ensure the timely routing and review of all master manufacturing records...

Career Category Manufacturing Job Description Specialist Contract Development & Manufacturing The Specialist, Contract Development & Manufacturing at Amgen provides technical support to the External Supply manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality. Working within a diverse Commercialisation & Performance Execution (CPE) team, this role works in partnership with different departments & stakeholders to ensure a smooth manufacturing process and compliance with quality standards. The role helps provide information insights and data analysis; identify problems and troubleshoot to evaluate options and solutions; drive precision through the execution of transactional/tactical tasks to ensure Amgen Contract & Development Manufacturing (ACDM) work cell (hub) success. The role also requires applying process, operational, and scientific expertise, as well as basic compliance knowledge...

Career Category Supply Chain Job Description Specialist Contract Development & Manufacturing The Specialist Contract Development & Manufacturing at Amgen provides oversight of New Product Introductions (NPI), technical support to the manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality. They liaise between different departments to ensure a smooth manufacturing process and compliance with quality standards.  They provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure Amgen Contract & Development Manufacturing (ACDM) work cell (hub) success. In this dynamic role, you will provide a strategic dimension to Amgen's manufacturing network to improve operational competitiveness and ensure uninterrupted global supply of medicines to our patients. Responsibilities: Project Management and Technology transfers: The role involves leading and...

Career Category Manufacturing Job Description Specialist Contract Development & Manufacturing The Specialist Contract Development & Manufacturing at Amgen provides oversight of New Product Introductions (NPI), technical support to the manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality. They liaise between different departments to ensure a smooth manufacturing process and compliance with quality standards.  They provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure Amgen Contract & Development Manufacturing (ACDM) work cell (hub) success. In this dynamic role, you will provide a strategic dimension to Amgen's manufacturing network to improve operational competitiveness and ensure uninterrupted global supply of medicines to our patients. Responsibilities: Project Management and Technology transfers: The role involves leading and...

Career Category Manufacturing Job Description Join Amgen’s Mission of Serving Patients     At Amgen, if you feel like   you’re   part of something bigger,   it’s   because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.     Since 1980,   we’ve   helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team,   you’ll   help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.     Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that   lie   within them,   you’ll   thrive as part...

Career Category Quality Job Description ABOUT AMGEN   At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.   Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.  ABOUT THE ROLE   In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations.   You will make key contributions to ensure high quality and right first time materials are received at...