Reporting to the Manager of GxP Quality Computer Systems you will support the content development and revisions of various procedural and validation documentation for GxP Digital System Lifecycle activities.
This is for an exciting project with a large company in the Life Science industry and an FDA regulated environment.
location: Cambridge, Massachusetts
job type: Contract
salary: $35 - 45 per hour
work hours: 8am to 5pm
- Author, design and manage CSV documentation (Plans and Summary Reports, Risk Assessments, Design Configuration/Specification, User and Functional Requirements, IQ/OQ, PQ, Trace Matrix, etc.).
- Transform business and functional requirements and technical info into effective and traceable testing.
- Support the implementation of processes and tools to maintain compliance.
- Evaluate, develop and revise Digital Process and Validation SOPs, Forms, and Documentation to meet business and regulatory requirements.
- Assist in editing documents for accuracy and ensures all comments and recommended revisions are addressed.
- Manage 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
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.