Deviation NCR Writer

Our client, a leading organization in the healthcare manufacturing industry, is seeking a Deviation NCR Writer to join their team. As a Deviation NCR Writer, you will be part of the Quality Assurance Department supporting compliance and process improvement initiatives. The ideal candidate will demonstrate strong problem-solving skills, attention to detail, and effective communication, which will align successfully in the organization.

Job Title: Deviation NCR Writer

Location:Round Lake, Illinois

• Perform non-conformance (NCR) investigations within the Track Wise 8 Management System.
• Execute implementation of CAPAs associated with NCR investigations.
• Maintain a high level of expertise in current regulatory requirements and serve as a plant resource for compliance to these requirements.
• Assist in maintaining audit-ready status for assigned areas and support other areas within the facility in compliance efforts.
• Provide guidance and coaching on performance of DMAIC problem solving and process improvement projects for less experienced team members.

• Understanding of the products' intended use and manufacturing processes.
• Ability to prioritize multiple tasks to ensure compliance with regulations and SOPs.
• Strong problem solving and analytical skills.
• Excellent written and verbal communication skills.
• Experience with Track Wise preferred; working knowledge of FDA Regulations and International Regulatory requirements.

• Opportunity to work onsite in a dynamic and innovative environment.
• Engagement in meaningful projects that impact healthcare quality and safety.
• Collaborative team culture that values continuous improvement and professional growth.
• Supportive environment for developing your regulatory and quality assurance expertise.
• Potential for extension or conversion based on performance and project needs.

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!