Sr Associate QA in England, United Kingdom

at Amgen

Medical Devices
Minimum Qualification
Bachelor's Degree
Required Experience
7 - 10 years
Employment Type
Full Time
Male or Female

Job Description

This 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


Master’s degree 
OR Bachelor’s degree and some experience directly related to the job OR Associate’s degree and substantial experience directly related to the job 
OR High school diploma / GED and substantial experience directly related to the job

Preferred Qualifications

Knowledge 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

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