Training Specialist

Job Title: Training /Quality Compliance Specialist

Location: New Brunswick, NJ

Duration: 06 months of Contract on W2

100% onsite

Work Schedule: Mon-Fri(normal business hours)

Bachelor's degree required

Must Haves:

• Experience with Training Management systems/principles (e.g., Success Factors, Compliance Wire) 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 with Deviations/ CAPA metrics/generation and management

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., CLIENTDocs/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.