Compliance Specialist
BCforward is currently seeking a highly motivated Compliance Specialist in New Brunswick, NJ
Job Title: Compliance Specialist
Duration: 6+ Months
Location: New Brunswick, NJ
Work Schedule: Mon-Fri(normal business hours)
Pay Range: $55- $58/Hr. on W2
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., Docs/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.
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.
Benefits: BCforward offers all eligible employees a comprehensive benefits package including, but not limited to major medical, HSA, dental, vision, employer-provided group life, voluntary life insurance, short-term disability, long-term disability, and 401k.
About BCforward: Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward's 6,000 consultants support more than 225 clients globally.
BCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class place to work.
BCforward is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.
To learn more about how BCforward collects and uses personal information as part of the recruiting process, view our Privacy Notice and CCPA Addendum. As part of the recruitment process, we may ask for you to disclose and provide us with various categories of personal information, including identifiers, professional information, commercial information, education information, and other related information. BCforward will only use this information to complete the recruitment process.
Interested candidates please send resume in Word format Please reference job code 237040 when responding to this ad.