PMTA Document Coordinator
1 week ago
Overview: Sesh Products US, Inc. 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.
As the PMTA Document Coordinator, you will work closely with our Operations, Customer Service, and Marketing teams to ensure regulatory compliance and support the integrity of our FDA-compliant QMS.
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.
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.
Salary Range: $65,000 - $85,000 per year
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