Life Sciences Engineering Material Management Sciences and related
Handson experience with change control processes and systems. Focused on commercial product life cycle manufacturing product variations and/or new product introduction.
Demonstrated ability on project management skills in balancing multiple responsibilities priorities tasks and projects simultaneously.
Experience on Quality roles
Quality contact for change controls and or deviations
Knowledge of SAP and Bill of material (BOM) management
Experience with Regulatory field
Strong organizational skills diligent and accurate analytical
Fluent and highly proficient in English and Spanish communication skills (verbal and written) as peers will communicate in English across multiple countries
Writing skills
(extra) Experience on managing quality systems and/or managing deviations (nonconformances).
(extra) Experience in scheduling and coordination around production schedules.
(extra) Smartsheet knowledge TrackWise (or equivalent quality or change control management) preferred MS Office
General Responsabilities
In a GMP environment design conceive progress and implement new or changes to existing customer facing (SKUs) change records (CFSCRs) within the Change Control Management quality system.
In a GMP environment design conceive progress and implement variants of product structures or intermediate SKUs to enable supply chain flow of product within the fill and finish site within the Change Control Management quality system.
Interpret strategies and navigates through artwork regulatory GMP systems and applicable technical assessments to ensure a compliant change is developed prioritized and progressed through all product stages in compliance with the respective guidelines and procedures.
Makes sound decisions and projects adjustments based on data from Regional Operations Leads planning tools production planners inventory s costs and resources capacity utilization.
Supports manager in leading all aspects of project(s) within Supply Chain: planning implementation monitoring followup completion and business partner meetings.
Reports communicates and presents metrics on variations implementations launch completions and other activities related to the life cycle management of the Amgen products.
May complete specific supply chain readiness projects and business cases.
Requirements
Candidates must qualify in years of experience and education as follows:
- Doctorate degree OR Masters degree and 2 years of Project Management experience
- Alternatively Bachelors degree and 4 years of Project Management experience
- Alternatively Associate s degree and 10 years of Project Management experience
- Alternatively High school diploma / GED and 12 years of Project Management experience.
Shift: MondayFriday 8 hours per day Administrative shift
Project manager 34123- Juncos -
