Associate Technical Writing (JP5008)

Location: Newbury Park, CA
Date Posted: 11-15-2018
Job Title:  Associate Technical Writing (JP5008)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit:  Corporate QA-DMS
Duration: 4+ months (likely extensions)
 
3Key Consulting Inc. is recruiting for an Associate Technical Writing with prior Amgen experience, QMS experience and ability to write GMP QMS documents for a global, CA-based, bio-pharmaceutical company.
 
Job Description:
Development and facilitation of the creation and/or revision of materials such as SOPs, manuals, and related business process documentation in conjunction with subject matter experts. Candidate must conduct these activities with the ability to deliver high quality documentation including technical writing in accordance with agreed timelines and in adherence with format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality.
 
  • Develops, writes, edits, and formats materials such as Quality Requirement Documents, Standard Operating Procedures, Business Practices, forms, checklists, technical manuals, installation guides, user manuals, and related technical and business process documentation.
  • When creating, updating and enhancing the documentation, adhere to format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality.
  • Administer the processing of documents via the established document management system and electronic document repository.
  • Communication through a variety of media (e.g., CD, intranet, on-line training, etc.).
 
Top Must-Have Skill Sets:
  • Prior Amgen experience.
  • Quality Management System knowledge and experience and excellent ability to write GMP Quality System documents (procedures and standards).
  • Manage multiple priorities and expectations simultaneously.
  • Ability to work independently and as a team player, demonstrating excellent collaboration and people management skills.
  • Proficient in discerning, high quality verbal and written communication and able to synthesize multiple inputs to propose a solution.
  • Be able to synthesize information and propose solutions.
  • Experience with Electronic Document Management system (preferred Documentum).
  • The manager is looking for specific technical documentation creation and more technical writing in their background- not looking for chemists or scientists.
  • We are looking for technical writers.
  • Must be a self-starter.
 
Day to Day Responsibilities
  • Interaction with multiple staff members to define requirements within GMP documents.
  • Writing, formatting and processing documents in approved document management system.
  • May lead meetings with cross-functional team members to determine path forward for document creation.
  • Track and provide regular updates, status reports or projected timelines for assigned tasked to key Points of Contact.
 
Basic Qualifications:
  • Experience in quality and compliance documentation.
  • Excellent communication/writing/collaboration
  • MS Office expertise; previous technical writing experience
  • Regulated environment experience.
  • Document version control experience.
 
Why This Position Is Open:
Supplement additional workload on team.
 
Employee Value Proposition:
This candidate will gain great exposure to quality elements of an organization and will see the entire quality process. They will also work with diverse multi-functional areas such as product development, operations, supply chain along with learning to master the electronic database for document management control.
 
Red Flags:
  • Demonstrates minimal decision-making skills.
  • Remote work.
  • Lack of exposure to quality and compliance documentation.
  • Lack of Quality System knowledge Inability to meet timelines Inexperience with document management systems.
 
Interview process:
Phone followed by in-person 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. You are also welcome to share this posting with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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