Document Control Manager

Position Summary The Document Control Manager oversees the company's controlled documentation program, ensuring compliant management of electronic and hard-copy documents across the organization. This role administers the Master Control eQMS (or equivalent) , maintains the training matrix , and ensures that procedures, records and training processes meet regulatory and operational requirements. The position also manages the issuance, control and reconciliation of batch records, laboratory logbooks and manufacturing logbooks , ensuring full traceability and audit readiness. Key Responsibilities Document Control and Records Management Lead the Document Control function, ensuring compliant creation, review, approval, issuance, revision, archival, and retirement of controlled documents. Maintain both electronic and hard-copy documentation repositories in accordance with the FDA and cGMP requirements. Ensure accurate version control, metadata integrity and document traceability. Oversee periodic document review, obsolescence management, and controlled distribution. Support internal/external audits by providing timely access to required documentation. Batch Record and Logbook Issuance Manage the issuance, tracking and reconciliation of Master Batch Records (MBRs) and executed batch records to Manufacturing. Ensure batch records are issued with correct revision levels, proper pagination and controlled identifiers. Maintain issuance logs and ensure timely retrieval and archival of executed records. Oversee the creation, issuance and control of laboratory logbooks and manufacturing logbooks, ensuring each is uniquely identified, traceable and compliant with data integrity expectations (ALCOA+). Monitor logbook usage, close-out and replacement to maintain continuous compliance MasterControl (or Equivalent eQMS) System Administration Serve as the primary System Administrator for MasterControl, including user/role management, workflow configuration, system maintenance and permission governance. Configure and optimize document workflows, training modules, change control routes and reporting dashboards. Manage system upgrades, validation activities and change controls for enhancements. Troubleshoot system issues, coordinate with IT and vendors, and ensure system uptime and date integrity. Maintain system SOPs, work instructions, OJTs and user training materials. Training Matrix and Training Program Oversight Own and maintain the company-wide training matrix, ensuring alignment with job roles, procedures and regulatory requirements. Manage training assignments, overdue training escalations and compliance reporting. Ensure training records are accurate, complete and audit-ready. Collaborate with functional leaders to update training curricula based on new or revised procedures. Generate training metrics, dashboards and compliance KPIs for management review. Quality Systems Support and Metrics Develop and maintain metrics related to document lifecycle performane, training compliance, batch record issuance and logbook control. Support continuous improvement initiatives to enhance document efficiency, training effectiveness and system performance. Participate in cross-functional quality improvement projects, SOP harmonization and QMS enhancements. Ensure alignment of documentation and training processes with corporate quality policies and regulatory expectations. Qualifications Required Bachelor's degree in a scientific, technical or quality-related field. 5+ years of experience in Document Control, Quality Systems or related QA/QMS roles. Hands-on experience with MasterControl or equivalent eQMS platforms. Strong understanding of document control principles, training compliance and regulated documentation practices. Experience in FDA-regulated or GxP environments. Excellent organizational, communication and project management skills. Preferred Experience issuing batch records (electronic and hard copies) and managing controlled logbooks in a GMP environment. Knowledge of 21 CFR Part 210, 211, 11, ALCOA+ data integrity and electronic records/e-signature requirements Experience supporting audits and regulatory inspections. Lean/Six Sigma or ASQ is a plus. Core Competencies Strong attention to detail and commitment to quality. Ability to collaborate aross departments and influence without authority. Analytical mindset with the ability to generate and interpret metrics. Proactive problem-solving and ontinuous improvement orientation. High integrity and professionalism in handling controlled information.

Pay:

From $70,000.00 per year

Benefits:

401(k) matching Dental insurance Disability insurance Employee discount Health insurance Life insurance Paid time off Vision insurance

Work Location:

Hybrid remote in Chantilly, VA 20151