Senior Document Control Specialist

Curia • Springfield, MO

11d

About The Position

The Senior Document Specialist helps protect the quality, accuracy, and integrity of documentation supporting Curia’s products, processes, and patients. Serving as a site resource for document control and records management, the role oversees controlled documents throughout their lifecycle, from creation, formatting, approval, and issuance through archiving, retention, retrieval, and disposition.

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

The position also supports change controls, investigations, CAPA plans, periodic quality reviews, document-control metrics, and the maintenance of document-control databases and tools. It uses document-management, quality, and business systems, and works with employees, leaders, customers, and cross-functional partners to resolve documentation issues. Work is performed in alignment with cGMP requirements, ALCOA++ principles, and site procedures.

Requirements

• 3–5 years of document control, records management, quality systems, or related experience in a GMP-regulated environment.
• Working knowledge of cGMP documentation practices, controlled-document lifecycles, records retention, and change control.
• Ability to read, interpret, and apply technical documents, safety requirements, operating instructions, procedure manuals, and regulatory or quality-system requirements.
• Strong written and verbal communication skills, including the ability to present information clearly, logically, and concisely.
• Strong proofreading, organizational, problem-solving, and time-management skills.
• Demonstrated attention to detail and ability to maintain accuracy while managing multiple priorities and deadlines.
• Ability to work independently, take initiative, exercise sound judgment, and collaborate effectively across departments.
• Proficiency with Microsoft Office applications, including Word, Excel, Outlook, and Access, or comparable database tools.
• Must pass a background check.
• Must pass a drug screen.
• May be required to pass Occupational Health Screening.

Nice To Haves

• Associate’s or Bachelor’s degree in a relevant field.
• Experience with TrackWise, ERP systems, or similar electronic document-management and quality-system platforms.
• In-depth experience creating, processing, implementing, and closing change controls.
• Experience supporting regulatory or customer audits.

Responsibilities

• Serve as a site 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 SOPs, forms, batch records, protocols, specifications, logbooks, and project notebooks.
• Establish and maintain organized electronic and hard-copy filing systems for secure and timely document storage and retrieval.
• Maintain 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 disposition of records received from site departments.
• 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 authorized before release.
• Serve as a site resource for document-related change controls, including 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 CAPA plans.
• Support regulatory and customer audits, including serving as an audit scribe and retrieving requested documentation.
• 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 to promote accurate documentation, data integrity, and inspection readiness.
• Support development and maintenance of the Logbook Database, Product Code Master List, Controlled Document List, and other document-control tools.
• Create and issue controlled logbooks and ensure associated records are properly maintained.
• Use document-management, quality, and business systems, such as TrackWise, ERP platforms, and Microsoft Office applications, to manage records and complete work.
• Identify opportunities to simplify document-control processes, improve accuracy, and strengthen the user experience while maintaining compliance.
• Train and coach employees on document-control requirements, SOP formatting, Microsoft Word, and the Controlled Document Management System.
• Translate technical requirements and written instructions into clear, practical guidance for document authors and users.
• Build effective working relationships with employees, leaders, customers, and cross-functional partners to identify and resolve documentation issues.
• Communicate questions, risks, and potential delays clearly and promptly, escalating concerns when additional support or decisions are needed.
• Organize and prioritize multiple assignments independently while remaining flexible and responsive to changing site and business needs.
• Perform documentation in compliance with ALCOA++ principles and site SOPs.
• Adhere to applicable cGMP documents, including SOPs, batch records, protocols, change controls, and controlled forms.
• Keep required cGMP training current and escalate quality concerns, along with proposed solutions, to the Quality department.

Benefits

• Generous benefit options, eligible first day of employment.
• Paid training, vacation, and holidays; vacation accrual begins on the first day of employment.
• Career advancement opportunities.
• Education reimbursement.
• 401K program with matching contributions.
• Learning platform.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed