Senior Document Control Specialist

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.

Benefits

• 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

About the Role

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.

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 TrackWise, ERP platforms, and Microsoft Office applications—to manage records and complete assigned work.
• Identify opportunities to simplify document-control processes, improve accuracy, and strengthen the user experience while maintaining compliance.

Training and Cross-Functional Partnership

• Train and coach employees on document-control requirements, SOP formatting, Microsoft Word, and the use of 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 in a timely manner.
• Communicate questions, risks, and potential delays clearly and promptly, escalating concerns when additional support or decisions are needed.
• Independently organize and prioritize multiple assignments while remaining flexible and responsive to changing site and business needs.

Good Manufacturing & Documentation Practices

• Perform your work in alignment with cGMP requirements and Curia’s standards to ensure our facilities support the safe and reliable manufacture of products for our customers.
• Perform all 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 all required cGMP training current and escalate quality concerns along with proposed solutions to the Quality department.

Requirements

Qualifications

• 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, with the ability to present information clearly, logically, and concisely.
• Strong proofreading, organizational, problem-solving, and time-management skills.
• Demonstrated attention to detail and the 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.

Preferred

• Associates 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.

Physical Requirements

The physical demands described below are representative of those required to successfully perform the essential functions of this role.

• Regularly required to sit, stand, walk, talk, and hear.
• Frequently required to use hands to handle or feel objects, reach with hands and arms, and climb, balance, stoop, kneel, crouch, or crawl.
• May occasionally lift and/or move up to 55 pounds.
• Visual requirements include close vision, distance vision, peripheral vision, color vision, depth perception, and the ability to adjust focus.

Work Environment

The work environment characteristics described below are representative of those encountered while performing the essential functions of this role.

• Regular work in a standard office environment, with intermittent entry into the production area of a pharmaceutical manufacturing facility.
• Production environment may include moving mechanical parts, fumes or airborne particles, extreme heat, wet or humid conditions, low levels of toxic or caustic chemicals, and outdoor weather conditions.
• Noise level in the work environment is typically moderate.

Other Qualifications

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Education, experience, location, and tenure may be considered along with internal equity when job offers are extended.