Job Description

Job Title: Compliance Specialist

Location: New Brunswick, NJ (08903)

Duration: 6 months

Work Schedule: Mon-Fri (normal business hours)

Job Description: 100% onsite

Must Haves:

• 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 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.

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