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Document Management Specialist (JP8407)

West Greenwich, Rhode Island · Biotech/Pharmaceutical
Job Title: Document Management Specialist (JP8407 )
Location: West Greenwich, Rhode Island 02817
Employment Type: Contract
Duration: 12 months with likely extensions
Job posting date:  4.2.21.
Note: Working on site 3-4 days a week
 
3 Key Consulting is hiring a Document Management Specialist for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
 
Job Summary:
  • Microsoft Office (expert level)
  • Experience working in Manufacturing / Quality Assurance or Quality Control (3 years of experience or more)
    GMP experience.
  • 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 Manufacturing 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, considering 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.
  • Liaison with other members of the QCA group (e.g., Business Process Modelers) and also the business (e.g., Business Process Owner, Document Owner, Authors, Subject Matter Experts).
  • Management of documents via the established Document Review process using the electronic document repository.
  • 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 pharmaceutical industry, with knowledge of quality and compliance.
  • Education: Engineering or Scientific background
 
Top Must have Skill Sets:
  • Microsoft Office (expert level)
  • Experience working in Manufacturing / Quality Assurance or Quality Control (3 years of experience or more)
  • GMP experience
 
Day-To-Day Responsibilities:
Expertise to provide the following services:
  • SOP development for approximately 60 documents in support of ABP 654 NPI.
  • Manufacturing process data analysis.
  • Deviation handling.
 
 
Employee Value Proposition:
exposure to new product introduction, supporting documentation. Cross functional team.
 
Red Flags:
Inexperience in GMP
 
Interview Process:
The plan is to conduct 2-round phone/video call interviews.
 
 
 
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 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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