Document Management Specialist (JP8470)
West Greenwich, RI. 02817 (Combination onsite and remote)
AR30 Manufacturing Project Support
6+ months (with likely extensions)
3 Key Consulting is hiring a Document Management Specialist
for a consulting engagement with our direct client, a leading global biopharmaceutical company.
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:
Why is the Position Open?
- 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
Top Must-Have Skill Sets:
Day to Day Responsibilities:
- 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.
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:
- 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.
They will get exposure to a new product plan from implementation to execution.
Inexperience in GMP.
Video Skype Panel Interview.
We invite qualified candidates to send your resume to firstname.lastname@example.org
. 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.