The QA/RA Administrator is responsible for reviewing and updating Quality Management System to align with current regulatory standards and guidance documents applicable to IVD/Medical Device (FDA 21 CFR 820, ISO13485: current, MDSAP, IVDR, etc.) conducting internal quality audits, supplier audits, corrective and preventive actions, complaint handling and non-conforming material process.
Biotechnology Jobs
Sr Regulatory Affairs Specialist Location: Miami Lakes, Florida, United States Requisition #: 19000A5D Post Date: 14 hours ago **SENIOR REGULATORY AFFAIRS SPECIALIST** In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives […]
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. We have a presence in more than 75 countries worldwide and have reached millions of people in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. […]
**Product Manager, Upstream Marketing, Transcatheter Heart Valves (THV)** **The Global Product Manager, Upstream Marketing, THV is responsible for developing and implementing new product planning and upstream marketing strategies for Edwards expandable access, and congenital pulmonic portfolios.** **This position will advance the Edwards transcatheter heart valve (THV) portfolio by managing upstream portfolio planning activities, analyzing market […]
Amgen is seeking a **Process Development Associate** – **Pivotal Drug Substance** to join our team and work from our beautiful Cambridge, Mass, campus. To learn more about this position: **Process Development Associate – Pivotal Drug Substance** The Pivotal Drug Substance Technologies organization at Amgen develops, characterizes and supports the commercialization of the drug substance manufacturing […]
The Manufacturing Associate position will execute production unit operations and other activities supporting clinical and commercial operations for drug substance manufacturing in stainless steel and single-use equipment. The Manufacturing Associate will monitor critical processes, execute routine validation protocols, and prepare documents such as Batch Records, SOPs and technical reports. They will perform basic troubleshooting and […]
Amgen (NASDAQ: AMGN), a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients. Amgen is seeking a […]
Location: Cambridge, MA or Thousand Oaks, CA Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of […]
This Manufacturing Senior Associate position will support the commissioning and start-up of commercial cell culture and purification of drug substance intermediate manufacturing operations in Thousand Oaks, CA. The Sr. Associate will coordinate and lead production operations on the manufacturing floor including taking a lead role in the commissioning and qualification of process equipment. This role […]
**Job Description:** Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high […]
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