Amgen Sr Associate QA in Singapore, Singapore

Role Description:Perform routine incoming QA disposition for incoming materials and cell banks

Provide quality oversight for supplier quality management (SQM) and contractor management which may include:Support resolution of quality issues from supplier investigations

Review and approve supplier / contractor management related nonconformances

Review site impact for supplier change notifications

Provide quality oversight in operations related to incoming materials, warehouse, procurement and shipping which may include (but not limited to)Review and approve standard operating procedures / documents related to Warehouse, Procurement, Incoming Material Sampling, Shipping Operations

Review non-conformances, corrective action / preventive actions (CAPA) and change controls associated with SAP ERP Material Master Data, Warehouse Operations and Shipping Operations

Review equipment use logbooks / cleaning logbooks related to incoming sampling and warehouse operations

Review and approve relevant commissioning and qualification / validation documents for warehouse operations

Serve as Trainer / Subject Matter Expert for SAP ERP Quality Transactions

Education / Licenses* Degree in Biological Sciences, Chemistry or Science related technological field

Relevant Experience

  • 2-4 years of relevant professional work experience within the pharmaceutical or biopharmaceutical industry, biopharmaceutical production experience preferred.

Competencies / SkillsShould have good understanding of GMP pharmaceutical operations

Good communication skills (technical writing and verbal communication/presentation)

Interact effectively with variety of communication and working styles and ability to work well in teams

Ability to manage multiple simultaneous activities in a rapidly changing environment

Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to incoming quality and supplier quality management

Ability to work independently with minimal supervision