Sr Associate QA

Category: Quality
Job ID: R-35645
Location: Singapore – Singapore
Posted Date: July 17, 2017
Job DescriptionThis role supports Amgen’s Quality Assurance program. Under general supervision, provides support and compliance oversight to MFG and F&E staff in the execution of their processes and procedures and use of quality systems EBR record review and closure SOP review and approval in EDMQ Review and approval of Cleaning Logs, EUR’s and Work Orders QA Contact on Class 1 Non-conformances and CAPAs, along with supporting Class 2 investigations, as needed Review and approval of validation documents (IQ, OQ, IOQ, FT) Represent PQA on project teams and Inspection Readiness (AIRP) Walk-Throughs.

Basic QualificationsMaster’s Degree OR Bachelor’s Degree & 2 years of Quality experience OR Associate’s degree & 6 years of Quality experience OR High school diploma/GED & 8 years of Quality experience

Preferred QualificationsKnowledge and training in QMTS, SAP, EBR and Maximo Strong organizational skills and ability to manage multiple tasks at one time Ability to follow assignments through to completion and meet timelines Self motivated Strong communication skills (both written and verbal) Demonstrated ability to work as both a team player and independently Ability to evaluate documentation and operations according to company procedures Ability to make decisions independently or elevate to management, as appropriate in an environment that balances business need, quality and compliance risk Strong word processing, database and spreadsheet application skills. The candidate will be required to work in 12 hours shift schedule.

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