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Document Management Specialist (JP7958)

West Greenwich, Rhode Island · Biotech/Pharmaceutical
Job Title: Document Management Specialist (JP7958)
Location: West Greenwich Rhode Island 02817
Employment Type: Contract
Duration:6 months with likely extensions
Job posting date: 24 November 2020
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:
The primary responsibilities may include, but are not limited to the following:
  • Development of regulated or process documents with the ability to deliver high quality documentation including technical writing.
  • Management of R&D 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.
  • Liaison with other members of the QCA group (e.g. Business Process Modellers) and also the business (e.g. Business Process Owner, Document Owner, Authors, Subject Matter Experts).
  • 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.
  • Education: Engineering or Scientific background

Top Must have Skill Sets:
  • Microsoft Office (expert level)
  • experience with working in Manufacturing / Quality Assurance or Quality Control (3 years of experience)
  • GMP experience
Day-To-Day Responsibilities:
Expertise to provide the following services:
· SOP development for approximately 60 documents in support of the ABP 654 NPI
· Manufacturing process data analysis
· Deviation handling
Employee Value Proposition:
Working in the single use manufacturing plant in North America, growing their skill set.
Red Flags: Inexperience with GMP
Interview Process: Phone/Video Call
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.
3KC Talent Acquisition Team

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