Document Control Associate II

Role Summary

The Quality Assurance Document Control Associate II assists with the management, organization, and maintenance of all quality-related documentation within the organization. This role ensures that all documents meet regulatory standards and are easily accessible for audits and reviews. The position works closely with various departments to ensure that documentation practices comply with internal and external quality standards.

Responsibilities

• Maintain all documents related to the manufacturing processes, including but not limited to executed batch records and Certificates of Analysis, within the EDMS
• Create batches within the electronic Quality Management System (QMS) and track and upload documents required for batch disposition
• Upload external documents to the EDMS for archival
• Follow policies, SOPs, and work instructions to support the document change control process, assign effective dates and training workflows, and archive documents
• Individual may assist in developing, managing, and maintaining Madrigal Standard Operating Procedures (SOPs), work instructions, protocols, and policies.
• Participate in periodic reviews of documents within the electronic document system to ensure formatting complies with current templates
• Manage document lifecycle, including creation, revision, approval, distribution, and archiving
• Assist with the creation of document control metrics, reports and dashboards
• Work in preparing and organizing documentation for internal and external audits
• Assist users with document related activities in the EDMS
• Assist departments with offsite archival of documents and maintain full traceability
• Maintain confidentiality and security of all documents and information
• Communicate effectively with team members and management to provide updates on document control activities
• Manages internal quality improvement initiatives: evaluate internal processes, and suggest/design/implement improvements
• Provides clerical and administrative support related to documentation processes and systems to include reviewing for conformance to document templates and format
• Pre-approves and routes documents for review and approval in Veeva QualityDocs.
• Responsible for filing and maintenance of GxP controlled documents and records. Ensures files are accurate and easily retrievable
• Provides additional support and assistance on tasks and projects as directed by management
• Operates as an effective liaison to internal corporate cross-functional areas, CMC/QA consultants, and external partners/contractors
• Participate in quality improvement initiatives and projects
• Stay updated on industry best practices and regulatory changes related to quality assurance documentation and maintain required knowledge of applicable regulations, guidelines, and company standards and procedures.

Qualifications

• BS/BA, with 3-5 years' experience, preferably in pharmaceutical and/or biotech environment in document control and management
• Experience with Veeva specifically Quality Docs, Training and QMS modules
• Proficiency in MS Word, Excel, Power Point, and DocuSign Part 11
• Candidate will have knowledge of GXPs, especially Good Documentation Practices and a good understanding of GMPs
• Excellent organizational and time management skills
• Strong attention to detail and accuracy
• Effective communication and interpersonal skills
• Knowledge and experience in development, and/or reviews of policies and procedures (i.e., policy documents and SOPs)