Specialist QA
Amgen - West Greenwich, RI

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This is for 3rd Shift (Tuesday - Friday 10pm - 8am) to support Amgen’s Quality Assurance program.
Position provides coaching, guidance and direction to MFG and F&E staff in
regards to compliance and quality systems and acts as the technical
specialist in one or more of the following:
EBR record review and closure
SOP review and approval in EDMQ.
QA Contact on Class 1 & 2 Non-conformances, CAPA and Change Controls
Review and approval of Cleaning Logs, EUR’s and Work Orders.
Review and approval of validation documents, environmental characterization
reports and release of sanitary utilities
Lead investigations and audits
May own site quality program procedures
Represent PQA on project teams and Inspection Readiness Walk Throughs
Develop and mentor junior staff

Basic Qualifications
Doctorate degree

OR

Master’s degree and 3 years of directly related experience

OR

Bachelor’s degree and 5 years of directly related experience

OR

Associate’s degree and 10 years of directly related experience

OR

High school diploma / GED and 12 years of directly related experience

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 skills

Amgen - 23 months ago - save job - copy to clipboard
About this company
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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...