Quality Compliance Specialist

Job Title: Compliance Specialist

Location: New Brunswick, NJ 08903

100% onsite

Duration: 06 Months contract (possibility to extend)

Work Schedule: Mon-Fri(normal business hours)

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., eDocs/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.

*Disclaimer: The responsibilities listed above are only a summary and other responsibilities may be added based on business needs.*