Quality Assurance Associate, Document Control

POSITION SUMMARY: The Quality Assurance (QA) Associate, Document Control is responsible for the administration and oversight of all quality-related documentation within the Quality Management (QMS). This role ensures that documents are maintained in compliance with regulatory requirements, company policies and procedures, and facilitating a state of audit readiness at all times. The QA Associate, Document Control works closely with cross-functional teams to support the document lifecycle, including creation, review, revision, approval, distribution, and archiving. PRINCIPAL RESPONSIBILITIES: Assist in organizing and maintaining all company documents, including the creation, updating, and filing of digital and physical records and act as a point of contact for document-related inquiries from internal team members. Ensure proper classification and version control of documents, making retrieval efficient. Support the company s document program through processes like scanning, indexing, and archiving. Support the implementation of document control procedures to maintain compliance with company policies, regulatory standards, and industry best practices (e.g. FDA, ISO, GMP). Assist in document approval process, ensuring timely updates, revisions and approvals while working cross-functionally with various departments. Assist in maintaining data integrity by regularly checking records for accuracy and completeness audit trails. Manage the issuance, distribution, and reconciliation of controlled documents to ensure proper use by different departments. Ensure secure storage of documents and assist with document retrieval and destruction or other document lifecycle functions. Support audits by preparing and organizing the required documentation and participates in regulatory agency (i.e. FDA, etc.) inspections. Compile and analyze metrics related to document control processes and quality assurance functions, providing insights for continuous improvement. Write, revise, review, and approve site procedures and policies. Ability to adapt quickly in a fast-paced dynamic environment. Ability to communicate with and positively influence broad and diverse populations within and outside the organization. Perform quality management system (QMS) functions as needed, such as assisting with the development or improvement of processes, risk assessments, or corrective and preventive actions (CAPA). Performs other duties as assigned by quality leadership to support continuous improvement and efficient operation of document control systems. Train employees on document control processes, policies, and the use of the electronic document management system (eDMS) to ensure compliance across the organization. Performs other duties as assigned.