Quality Assurance Senior Specialist - Thousand Oaks

Company: Infotree Global Solutions
Your Application: You have not applied yet
Location: Thousand Oaks, USA
*** Remote***

Amgen requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at Amgen. In accordance with applicable law, Amgen will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

At Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the world s leading biotechnology companies. We are global collaborators who achieve together researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide.

The Quality Management System is the foundation of all that we manufacture, test, and store at Amgen to support our biggest mission, to serve the patients. This position will support the global Document Management process and a network of Subject Matter professionals to assure the documents generated at Amgen to support our Quality Management System are controlled, effective, and efficient.

Reporting to the Global Process Owner of Document Management this position sits in Corporate Quality Systems and is part of a very versatile team. This is a remote role and includes flexible working
hours to support Amgen s global footprint.

Key Responsibilities:

Support the global network to cascade requirements and QMS architecture to Amgen sites and functions
Manage and execute project deliverables to eliminate document redundancies, optimize document content, and ensure compliance
Collaborate with document owners and global process owners in the assessment of controlled documents and resulting actions
Authors, reviews or approves procedures, documentation and training material

In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role

Preferred Qualifications
Degree educated with 7+ years of experience in a pharmaceutical/drug/device manufacturing environment
Well-rounded knowledge Quality Management Systems, especially Document Management
Project Management and Data Analytics
Understanding of Device / Combination Product Regulations
Strong organizational, communication, coordination, and meeting facilitation skills
Independent, self-motivated, organized, able to multi-task across a global network
Cultural awareness and dexterity
Innovation mentality with aptitude for developing ideas into measurable objectives
Experience with collaboration tools such as Teams, Smartsheets, Miro etc. EnteredNameComment01/14/2022 05:22 PM-Reason: Position Filled01/04/2022 04:44 PM-Reason: Halt Job Posting

Work Day: Full Time
Salary: Negotiable

Minimal experience: No experience

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