What are the responsibilities and job description for the GxP documentation specalist position at Umanist Staffing?
100% onsite
Work Schedule: Mon-Fri(normal business hours)
Location: New Brunswick
Role Overview:
This role is a key position within the CSO organization to ensure day-to-day compliance with GxP documentation and training. The candidate will work with multiple departments across Product Development to effectively communicate and manage all training and GxP documentation-related issues. The position is responsible for managing controlled documentation (Standard Operating Procedures, Forms, other controlled documents, Training docs etc.) for the team.
Education:
Bachelor's degree required in field of science
Responsibilities:
Training and Documentation:
- Handle daily training and documentation tasks, ensuring compliance with GxP documentation and data integrity principles.
- As trainee SME, develop and evaluate training curricula, monitor training materials, and assess program effectiveness.
- Conduct training impact assessments and create Role Based Training matrices.
- Generate training metrics, create job aids/end- to-end workflows and conduct team trainings as required.
Content Management:
- Manage PD Electronic Document Management Systems (e.g., BMSDocs/Veeva) by creating, reviewing, and maintaining CSO-controlled documents.
- Oversee documents scheduled for periodic reviews and updates related to CAPAs.
Digital Solutions and SharePoint Management:
- Establish and manage a SharePoint site to enhance team communication and collaboration.
- Identify, implement and support digital solutions to replace paper-based processes or enhance existing processes.
- Evaluate and recommend electronic solutions to streamline workflows.
Quality and Compliance:
- Perform quality investigations, including root cause analysis, CAPAs and ensure timely completion of investigations.
- Ensure compliance with GxP documentation and data integrity principles in daily work.
Continuous Improvement:
- Identify opportunities for process optimization and implement best practices.
- Collaborate with cross-functional teams to drive continuous improvement initiatives.
- Monitor and analyze performance metrics to identify areas for improvement.
- Facilitate training sessions and workshops to promote a culture of continuous improvement.
Team Collaboration and Problem Solving:
- Address day-to-day challenges independently in a timely and professional manner.
- Collaborate effectively with team members to resolve routine issues.
- Exercise good judgment in identifying when to escalate technical or business challenges to upper management
Key Skills:
- Proficiency in Excel, Word, Visio, SharePoint, PowerPoint, etc.
- Experience with Training Management systems/principles (e.g., SuccessFactors, ComplianceWire) and QMS Documentation Systems (e.g., EDMS, Veeva).
- Strong background in Good Manufacturing Practices (GMP) and GxP documentation, with familiarity with Data Integrity principles.
- Experience in deviation writing, change controls, etc.
- Highly experienced in creating, managing, and maintaining SharePoint sites; experience with AI tools is a plus.
- Excellent attention to detail with the ability to work accurately and independently in a busy, demanding environment.
- Strong collaboration and communication skills.
- Ability to work within strict timelines, showcasing excellent organizational and time management skills.
- Ability to negotiate and act as a mediator between functional areas while meeting timelines and paying attention to details.
Job Type: Contract
Pay: $50.00 - $52.00 per hour
Expected hours: 40 per week
Work Location: On the road
Salary : $50 - $52
