Specialist Technical Writer – Bio-pharma (JP4819)
Woburn, MA 01801
5 months with likely extension
ARI Mfg Upstream Operations
3Key Consulting Inc. is looking for role for a Specialist Technical Writer
with experience in
supporting manufacturing operations, quality records in Trackwise, for a global, CA-based, bio-pharmaceutical company.
Job Details: Develops, writes, edits, and formats materials such as Standard Operating Procedures, Business Practices, forms, checklists, technical manuals, installation guides, user manuals, and related technical and business process documentation. When creating, updating and enhancing the documentation, adhere to format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality. Additionally, this position will be required to administer the processing of documents via the established Document Processing Review process. May require communication through a variety of media (e.g., CD, intranet, on-line training, etc.)
- MS Office expertise
- Previous technical writing experience
- Regulated environment experience
- Document version control experience
- Excellent communication/writing skills
This position is more focused on Technical Writing. Ownership of quality records for manufacturing area such as Non-conformances, CAPAs and Change controls.
Years of Experience
: 5 years of experience supporting manufacturing operations at a Bio-Pharm/Pharma Company.
Bachelors Degree or higher
Primary responsibilities of this position include
Work on technical documentation present on the findings. Manage quality records - cross functional work.
Top Must Have Skill Sets:
Employee Value Proposition:
- Technical Writing
- Project Management skills
- Quality Records in Trackwise
This is both drug substance and drug product operations within the same plant. This could expand the persons knowledge and experience. This is a great place to learn.
: No technical writing background.
30-minute phone screening to in-person interviews. Plan to begin phone screens Monday 10/15.
We invite qualified candidates to send your resume to email@example.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. You are also welcome to share this posting with anyone you think might be interested in applying for this role.