Team Lead, Document Control en None

The Team Lead Document Control position is a leadership role responsible for overseeing document management, quality control support, and process improvement initiatives. This position plays a vital role in maintaining regulatory compliance and operational efficiency by managing and optimizing physical and digital archives, coordinating document control activities, and providing expertise on document management practices. Additionally, the Team Lead Document Control is accountable for coordinating continuous improvement projects and ensuring that document storage areas are organized, presentable, and secure.  This role provides leadership by guiding, mentoring, and supporting team members, fostering a collaborative work environment, and ensuring alignment with departmental and organizational goals. Directly supervises individual contributors. This position is on-site. 

Duties and Responsibilities: 

• Manages and updates the Master Document List to ensure accurate tracking and compliance.
• Responsible for providing leadership to a team, including assigning tasks, managing priorities, and directing projects to successful completion.
• Ensures compliance with CGMP requirements within a manufacturing environment.
• Oversees the organization, accessibility, and security of physical and digital archives, maintaining clean and organized storage areas and managing access control to ensure regulatory compliance.
• Leads document disposition processes, including completing customer disposition letters and overseeing secure document disposal, while leading continuous improvement initiatives within the Document Control team to enhance efficiency and compliance.
• Serves as the Subject Matter Expert (SME) for document control processes and as the Document Control Team Lead, overseeing and coordinating the activities of team members within the document control function to ensure efficiency, accuracy, and compliance with organizational standards.
• Accurately performs data entry in Excel or LIMS (Laboratory Information Management System) for trending purposes, creating control charts and analyzing data as necessary to support quality control and process improvement initiatives.
• Reviews and manages the archive Check-In/Check-Out Log, following up to reconcile and correct entries as required, ensuring consistent documentation control.
• Manages the full lifecycle of document archiving, from scanning and review to destruction, and coordinates with customers for required documentation approvals.
• Proactively communicate timelines and statuses of requests, identifying potential issues and providing solutions.
• Issue, track, and manage controlled documents, including labels, reconciliations, production records, and quality control documents.
• Review completed production and QC document packets for errors, completeness, and readiness for filing. Identify and correct discrepancies as necessary.
• Scan, review, and organize electronic files and folders, ensuring accuracy, completeness, and data integrity (including QC data and production records).
• Maintains hardcopy documents and electronic archives, including production, QC, and raw material records, in accordance with established procedures, ensuring materials are accurately matched with Material Status Sheets.
• Maintain spreadsheets and logs to track document status and locations. Ensure accurate archival documentation.
• Additional duties may be assigned by management as needed, including responsibilities typically associated with lower-level positions to ensure operational flexibility and support.

EDUCATION AND EXPERIENCE

• High school diploma or equivalent;
• 3-5 years of experience in document management, quality control, or a related field; and 
• Minimum 2 years of supervisory experience.

COMPETENCIES/SKILLS

• Advanced knowledge of document control systems, archival processes, and regulatory compliance.
• Proficiency in Microsoft Excel, data management systems, and LIMS.
• Experience in coordinating and leading improvement projects.
• Strong organizational, communication, and analytical skills.

This job description does not constitute a contract of employment or otherwise limit employment-at-will rights at any time