Document Control & QMS Specialist
: Job Details :

Purpose of Job

At Sesh Products US, Inc., the makers of Sesh+, we are dedicated to ensuring the highest regulatory standards and compliance for our products. We're looking for a detail-oriented Document Control & QMS Specialist who can effectively collaborate with our Operations, Customer Service, Marketing teams, suppliers, and contract manufacturers. This role is integral to our Quality and Compliance Team, where you'll work closely on regulatory requirements around the Premarket Tobacco Application (PMTA) process, managing documents, maintaining accurate records, and ensuring that our Quality Management System (QMS) aligns with FDA standards for tobacco and nicotine products.

About Sesh Products US, Inc.

Sesh Products US, Inc., through our Sesh+ line, is a fast-growing, innovative CPG brand in the nicotine space, committed to delivering safe, compliant, and high-quality products to consumers. Our company champions better, less harmful alternatives and leads with a focus on strict quality and regulatory standards. Joining our team means becoming a vital part of our mission to elevate product safety and regulatory compliance.

Summary

As the Document Control & QMS Specialist, you will play a critical role in the execution, monitoring, and continuous improvement of our production, quality, and regulatory compliance programs. Reporting to the Director of Compliance, you'll manage document lifecycles related to our PMTA submissions and ensure all documentation complies with regulatory requirements. This role involves close collaboration with internal and external stakeholders to uphold the integrity of our FDA-compliant QMS.

Key Responsibilities

• PMTA Document Management: Manage and oversee controlled document updates, specifically around PMTA submissions, policies, and regulatory instructions.
• Document Lifecycle: Coordinate document preparation, routing, review, approval, distribution, and archival in line with FDA PMTA guidelines.
• Change Management: Process change orders for PMTA-related documents and regulatory requirements.
• Organize Regulatory Files: Ensure accurate filing systems for PMTA and other regulatory documents.
• Data Compilation: Prepare data for QA meetings, management reviews, and supplier reviews.
• Audit Preparation: Support internal and external audits, especially in relation to PMTA requirements and compliance.
• Non-Conformance & Complaints: Manage non-conformance documentation and assist in resolving regulatory-related customer complaints.
• Training Coordination: Train staff on PMTA documentation protocols and maintain up-to-date training records.
• Batch Record Review & Supplier Qualification: Ensure batch records align with PMTA compliance standards and assist in supplier qualification activities.

Job Requirements

• Industry Experience: 1-2 years in food, pharmaceutical, or tobacco products, with regulatory knowledge preferred.
• Attention to Detail: Strong organizational skills and a meticulous eye for detail, especially in regulatory documentation.
• Knowledge of Standards: Familiarity with GMP, HACCP, QMS, and regulatory standards, with PMTA knowledge as a plus.
• Technical Proficiency: Proficient in Microsoft Office (Word, Excel, PowerPoint); a certificate is preferred.
• Communication Skills: Ability to conduct training sessions and speak effectively to groups.
• Proactive Problem Solving: Strong focus on continuous improvements in document management and quality processes.

Physical Requirements

This is an office-based role, requiring the ability to sit for extended periods.

If you are ready to take on a regulatory-focused role that supports the integrity and safety of Sesh Products US, Inc. and our Sesh+ line, we encourage you to apply. Join us and be part of a team dedicated to upholding excellence in compliance and quality.