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Quality Assurance Senior Specialist - Remote (JP9604)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:   Quality Assurance Senior Specialist - Remote (JP9604)
Location: Thousand Oaks, CA. 100% REMOTE
Employment Type:  Contract
Business Unit: Quality Systems
Duration: 14+ months with likely extensions
Posting Date: 12/28/2021
Rate: $30-35/Hr W2

Notes: Remote

3 Key Consulting is hiring a Quality Assurance Senior Specialist for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
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.

Why is the Position Open?
Supplement additional workload on team.

Top Must Have Skills:
  • Project Management
  • Quality Management System Documentation
  • Work in Teams
  • Proficiency in Microsoft suite
  • Scrum experience preferred
  • Agile experience preferred
  • Strong organizational, communication, coordination, and meeting facilitation skills
  • Lean six sigma certification preferred

Day to Day 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

Employee Value Proposition:
The person in this role would be working with Veeva and applying processes to the system. You will also learn implementation of quality documentation at a higher level.

Red Flags:
  • No Quality experience.
  • No project management experience.
  • No cross-functional experience.

Interview process:
Video Skype Panel Interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

3KC Talent Acquisition Team
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