Compliance Specialist

Company: Joul--
Location: New Brunswick
Posted on: April 20, 2025

Job Description:

Job Title: Compliance Specialist

Have you got what it takes to succeed The following information should be read carefully by all candidates.
Location: New Brunswick, NJ
Hours/Schedule: Mon-Fri (normal business hours)
Type: Contract

Overview
Leading pharmaceutical company looking for an experienced Compliance Specialist. Ideal candidates should have experience with Deviations, CAPA metrics/generation and management within a GMP environment.

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., 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


Requirements Proficiency in Excel, Word, Visio, SharePoint, PowerPoint, etc.
Experience with Training Management systems/principles (e.g., SuccessFactors, 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 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.



Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.




Ref: #568-Clinical
Ref: #558-Scientific

Keywords: Joul--, Cherry Hill , Compliance Specialist, Other , New Brunswick, New Jersey