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
Master’s degree and 3 years of directly related experience
Bachelor’s degree and 5 years of directly related experience
Associate’s degree and 10 years of directly related experience
High school diploma / GED and 12 years of directly related experience
Demonstrated experience in investigations, change control, validation and
System knowledge and training in QMTS, SAP, EBR, Maximo and CCMS
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
Amgen - 18 months ago
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...