Senior Document Control Specialist

Job Description

Senior Document Specialist in Springfield, MO

Build your future at Curia, where our work has the power to save lives

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

We proudly offer

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

The Senior Document Specialist helps protect the quality, accuracy, and integrity of the documentation that supports our products, processes, and patients. Serving as a site resource for document control and records management, this role oversees the lifecycle of controlled documents—from creation, formatting, approval, and issuance through archiving, retention, retrieval, and disposition.

The Senior Document Specialist partners across the site to keep documentation accurate, accessible, inspection-ready, and compliant with current Good Manufacturing Practices (cGMP). This position also provides guidance and training to employees, supports audits and quality-system activities, and proactively resolves document-related issues. Success in this role requires strong attention to detail, sound judgment, clear communication, and a collaborative approach to getting work done right.

Essential Responsibilities

Document Control and Records Management

• Serve as a site subject matter resource for controlled documents, records management, file processing, version control, and document distribution.
• Format, route for approval, master, issue, distribute, revise, and retire controlled documents, including standard operating procedures, forms, batch records, protocols, specifications, logbooks, and project notebooks.
• Establish and maintain organized electronic and hard-copy filing systems that support accurate, secure, and timely document storage and retrieval.
• Maintain complete and accurate document files, databases, indexes, and tracking records in accordance with cGMP, company procedures, and retention requirements.
• Prepare, archive, track, retrieve, store, and coordinate the appropriate disposition of records received from departments across the site.
• Manage the mandatory SOP review process and follow up with document owners to support timely completion.
• Issue master batch records for manufacturing and scan executed batch records to designated customer portals.
• Review, proof, and coordinate document requests from customers and other external parties, ensuring information is accurate and appropriately authorized before release.

Quality Systems and Compliance Support

• Serve as a site resource for document-related change controls, including their creation, evaluation, tracking, implementation, and closure.
• Track and process assigned change controls through completion, partnering with document owners and cross-functional teams to address delays or issues.
• Support investigations and the execution and documentation of corrective and preventive action (CAPA) plans.
• Support regulatory and customer audits, including serving as an audit scribe and retrieving requested documentation accurately and efficiently.
• Assist with Annual Product Reviews and other periodic quality reviews.
• Develop, maintain, and report document-control and Quality System metrics for management review.
• Apply cGMP principles and site procedures consistently to promote accurate documentation, data integrity, and continuous inspection readiness.

Systems, Databases, and Operational Support

• Support the development and maintenance of the Logbook Database, Product Code Master List, Controlled Document List, and other document-control tools.
• Create and issue controlled logbooks, as appropriate, and ensure associated records are properly maintained.
• Use document-management, quality, and business systems—such as Track Wise, ERP…