Document Management Specialist, Biopharma (JP5179)

Location: Thousand Oaks, CA
Date Posted: 01-07-2019
Job Title:  Document Management Specialist, Biopharma (JP5179)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit:  Final Product Technologies Usability Engineering
Duration: 12 months with likely extensions
 
3Key Consulting Inc. is recruiting for a Document Management Specialist with 3-5 years’ experience in Quality or document control and background in Medical Device or regulated industry experience, for a global, CA-based, bio-pharmaceutical company.
 
Job Description:
Development of regulated or process documents with the ability to deliver high quality documentation including technical writing. The primary responsibilities may include but are not limited to the following:
Management of process documentation per required process (e.g. Standard Operating Procedure [SOP] on SOPs) in accordance with agreed timelines and in adherence with format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality. 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. Note: these activities will usually take place virtually and across different time zones. Management of documents via the established R&D Document Review process using the electronic document repository (EDM Quality). Track and provide regular updates to process project inventory tool and to key Points of Contact. Requirements include: Experience in developing regulated or process documents with the ability to deliver high quality documentation including technical writing. Sound project management and organizational skills. Ability to work independently and as a team player, demonstrating excellent collaboration and people management skills, preferably to include experience in influencing and negotiation. Experience in leading virtual teams within different regions and cultures. Proficient in discerning, high quality verbal and written communication. Experience of electronic clinical trial/SOP/document systems (e.g., Documentum). Good working knowledge of Microsoft Word. 3+ years’ experience preferably in R&D/pharmaceutical industry, with knowledge of quality and compliance
 
Top Must-Have Skill Sets:
  1. Solutions driven
  2. Adaptable
  3. 3-5 years’ experience in Quality or document control
  4. Medical Device or regulated industry experience
 
Day to Day Responsibilities:
  • Draft, or Review, also manage EDMQ workflows for Protocols, Studies, Reports, Technical Assessments as needed.
  • Building and supporting maintenance of Usability Engineering File by program/ platform
  • Support regulatory submissions, design review deliverables, and RTQs Build data management system for storage and archival of HF studies
  • Data Verify controlled documents
 
Employee Value Proposition:
This team has a responsibility is to assure that the use of the product/device is safe, fully vetted and de-risked. Their main focus is to help the users want to use the device. Learning and understanding human factors is quickly growing role in this industry so this opportunity will position the candidate for a successful future.
 
Red Flags:
  • Too many jobs No medical device or regulated industry experience Typos, spelling errors in resume
  • Candidates directly out of college will not be considered
  • We are NOT looking for entry level document control candidates.

Interview process: 
Phone screen - with 3 HF staff members Onsite interviews 1/2 day
 
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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