logo

View all jobs

Document Management Specialist, Biopharma - Remote (JP10009)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Document Management Specialist, Biopharma - Remote (JP10009)
Location: Thousand Oaks, CA (Remote)
Business Unit:
Quality Systems

Employment Type: Contract
Duration: 10 months with likely extensions
Job posting date: 4/7/2022

3 Key Consulting is hiring a Document Management Specialist-Remote for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:

The Quality Management System (QMS) is the foundation of all that we manufacture, test, and store 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 company to support our Quality Management System are controlled, effective, and efficient.

Key Responsibilities:
  • Support the global network to cascade requirements and QMS architecture to client’s sites and functions in accordance with agreed timelines ensuring accuracy, consistency and quality
  • Manage and execute project deliverables to eliminate document redundancies, optimize document content, and ensure compliance
  • Collaborate with document owners, subject matter experts and global process owners in the assessment of controlled documents and resulting actions in accordance with agreed timelines ensuring accuracy, consistency and quality
  • Management and facilitation of process documentation including authoring, reviewing or approving procedures, documentation and training material

Top Must have Skill Sets:
  • Well-rounded knowledge Quality Management Systems, especially Document Management
  • Strong organizational, communication, coordination, and meeting facilitation skills
  • Veeva Document Management System preferred, be document principles a must
  • Understanding of documentation execution principles in the pharma industry
  • High level experience w/ project management

Preferred Qualifications
  • 7+ years of experience in a pharmaceutical/drug/device manufacturing environment
  • Experience in developing regulated or process documents with the ability to deliver high quality documentation
  • Well-rounded knowledge Quality Management Systems, especially Document Management
  • Understanding of Device / Combination Product Regulations
  • Project Management and Data Analytics
  • Strong organizational, communication, coordination, and meeting facilitation skills
  • Independent, self-motivated, organized, able to execute multiple outputs across a global network
  • Innovation mentality with aptitude for developing ideas into measurable objectives
  • Cultural awareness and dexterity
  • Experience with collaboration tools such as Teams, Smartsheets, Miro etc.

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

Employee Value Proposition:
Growth/ opportunity

Red Flags:
  • Unfamiliar with Document Management principles (pharma industry preferred)
  • Unfamiliar with Quality and Quality Management Systems principles, must have QMS experience
  • Frequent job changes in short period of time

Interview Process:
Phone screen, then virtual interview with hiring manager and their supervisor

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

 
 
Regards,
 
3KC Talent Acquisition Team
 
 
Powered by