: Document Management Specialist (JP7958)
West Greenwich Rhode Island 02817
:6 months with likely extensions
Job posting date
: 24 November 2020
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.
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.
Top Must have Skill Sets:
- 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
- Microsoft Office (expert level)
- experience with working in Manufacturing / Quality Assurance or Quality Control (3 years of experience)
- GMP experience
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.
: Inexperience with GMP
We invite qualified candidates to send your resume to firstname.lastname@example.org. 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.