Specialist QA
Amgen - West Greenwich, RI

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Provides Quality oversight, coaching, guidance and direction to MFG and F&E
• Provides Quality oversight on the floor:
o Electronic Batch Record Review and Closure
o QA Contact for Non-conformances, CAPA and Change Controls
o Review and approval of Cleaning Logs, Equipment Use Records and Work Orders
o Participates in daily client meetings
o Represent PQA on project teams and Inspection Readiness Walk Throughs
o Develop and mentor junior staff
• Champions operational excellence / lean transformation
• Review and approval of validation documents, environmental characterization reports and release of sanitary utilities
• Key participant in audits/inspections
Basic Qualifications
Doctorate degree OR Master’s degree & 3 years of experience directly related to the job OR Bachelor’s degree & 5 years of experience directly related to the job OR Associate’s degree & 10 years of experience directly related to the job OR High school diploma / GED & 12 years of experience directly related to the job
Preferred Qualifications
Demonstrated experience in investigations, change control, validation and
audits
System knowledge and training in QMTS, SAP, EBR, Maximo and CCMS
Self motivated
Strong organizational skills and ability to manage multiple tasks at one time
Ability to follow assignments through to completion and meet timelines
Strong communication skills, (both written and oral), facilitation and
presentation skill

Amgen - 10 months ago - save job - block
About this company
143 reviews
Amgen is among the biggest of the biotech big'uns, and it's determined to get even bigger. The company uses cellular biology and medicinal...