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Document Control Specialist
2 months ago
The Document Control Specialist at NutraStar-West will play a key role in leading and refining our specification process. This position is responsible for designing and implementing internal technical documentation, including product specifications for finished goods. As the Document Control Specialist, you will be the primary liaison between Product Development, Operations, Packaging, CAPA, MRB, and Change Control subject matter experts within the Quality Assurance group. You will manage the end-to-end process of finished goods specifications, ensuring compliance with industry standards and regulatory requirements.
- Oversee the creation and revision of internal technical documentation related to product specifications, interfacing with SME specification creators in product development, packaging, operations, regulatory affairs, and quality assurance.
- Ensure all specifications are accurate, up-to-date, and compliant with NutraStar regulatory standards.
- Own the end-to-end specification process for finished goods and interface with external partners on implementation.
- Oversee the inputs of information to connect finished goods to the final bill of materials, ensuring label and documentation compliance.
- Maintain the technical database on finished goods.
- Lead Document Control requirements for the Quality Team. Prepare forms, collect signatures, and issue out change orders.
- Act as the primary point of contact between product development, packaging, operations, regulatory affairs, and change control subject matter experts.
- Facilitate cross-functional meetings to ensure alignment on specification requirements and changes.
- Collaborate with quality assurance to integrate specification updates into the overall quality management system.
- Participate in the initiation of change requests, revisions and reviews for accuracy, routing for approvals, and implementation of changes at contract manufacturers.
- Identify opportunities for improving the specification process and implement best practices.
- Develop and enforce standard operating procedures (SOPs) related to specification management.
- Documentation and Record-Keeping
- Maintain accurate and comprehensive records of all specifications and related documents.
- Ensure proper documentation of specification changes and approvals.
- Provide regular reports on specification status and updates to management.
- Receive, review, categorize, and track documents, ensuring standardization, accuracy, and completeness.
- Train and support internal teams on specification requirements and processes.
- Provide guidance on regulatory and technical documentation to ensure compliance and quality.
- Participate in QA Compliance activities by developing, training, and implementing SOPs as needed.
- Support other QA activities as needed.
PAY: DOE
Onsite position