Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:
Date Posted: 1/23/2019
Hiring Organization: Connexion Systems & Engineering
Job Title: Technical Writer – GxP Digital Quality Systems
Location: Cambridge, MA 02138
Employment Type: Full Time, Contract
Pay Range: 45-47/hr.
Duration: 6 months
Technical Writer, GxP Digital Quality Systems
Reporting to the Senior Manager of GxP Quality Computer Systems. The Technical Writer/Analyst Role will support the content development and revisions of various procedural and validation documentation for GxP Digital System Lifecycle activities.
Author, design and manage computerized system validation (CSV) documentation (Plans and Summary Reports, Risk Assessments, Design Configuration/Specification, User and Functional Requirements, IQ/OQ, PQ, Trace Matrix, etc.).
- Transforms business and functional requirements and technical information into effective and traceable testing.
- Supports the implementation of processes and/or tools to maintain compliance.
- Evaluates, develops and revises Digital Process and Validation SOPs, Forms, and Documentation to meet business and regulatory requirements.
- Assists in editing documents for accuracy and ensures all comments and recommended revisions are addressed.
- Manages documentation, tracks dates and versions of documents to ensures that documents are updated according to project and SOP requirements.
- Verifies all documents for a given project are completed and processed.
- Ensures current documentation status is maintained/updated within project trackers.
- Manages or assists SMEs with Change Controls.
- Provides GxP Digital team with technical writing assistance
- Bachelor’s Degree in a scientific background or another relevant academic discipline.
- At least 3-5 years of demonstrated experience designing, implementing, and supporting compliance systems in FDA regulated industry.
- Knowledge of cGxP, 21 CFR Part 11, Annex 11, GAMP 5 is highly desirable.
- Experience with SDLC methodologies in a cGxP regulated environment.
- Excellent documentation and communications skills.
- Strong interpersonal skills with ability to work collaboratively within a team of stakeholders.
- Self-directed with effective analytical and problem-solving skills.
- Capable of operating within a fast-moving business environment.
- Familiarity and experience with electronic document management systems and automated software testing system a plus
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ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776