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Document Management Specialist (JP8470)

West Greenwich, RI · Biotech/Pharmaceutical
Job Title:  Document Management Specialist (JP8470)
Location: West Greenwich, RI. 02817 (Combination onsite and remote)
Employment Type:  Contract
Business Unit: AR30 Manufacturing Project Support
Duration: 6+ months (with likely extensions)
Posting Date: 4/8/21
 
 
3 Key Consulting is hiring a Document Management Specialist for a consulting engagement with our direct client, a leading global biopharmaceutical 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 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, 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 Document Review process using the electronic document repository.
  • Track and provide regular updates to process project inventory tool and to key Points of Contact
 
Why is the Position Open?
Backfill.
 
Top Must-Have Skill Sets:
  • Microsoft Office - Word(expert level).
  • Experience working in Manufacturing / Quality Assurance or Quality Control (3 years of experience or more)-pharma experience is a plus; other industries is fine if they have experience with GMP regulations.
  • GMP experience - 3 years.
 
 
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
 
 
Basic Qualifications:
  • Engineering or Scientific background.
  • 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.
 
 
Employee Value Proposition:
They will get exposure to a new product plan from implementation to execution.
 
 
Red Flags:
Inexperience in GMP.
 
 
Interview process:
Video Skype Panel 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/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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