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Description
auto req 11910br
job posting title sr associate qa
career category quality
employee subgroup salaried ft
country (state/region) ireland
location (city) dun laoghaire
amgen job description this role supports amgen\'s quality assurance program. 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, along with supporting class 2 investigations, eur\'s and work orders
qa contact on class 1 non-conformances and capas, as needed
review and approval of validation documents (iq, oq, ioq, ft)
represent pqa on project teams and inspection readiness (airp) walk-throughs
basic qualifciations high school diploma with significant dircetly reltaed experience
preferred qualifications - dergee qualfiied with directly related expereiince
- knoweldge and traniing in qmts, ebr and maixmo
- storng organiaztional 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, sap, quality and compliance risk
- strong word processing, as appropriate in an environment that balances business need, database and spreadsheet application skills,
under general supervision.
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