Document Control Associate
Job Title: Document Control Associate Type: Contract Location: Remote Experience: 0–2 years Job Summary The Document Control Associate supports document management activities within pharmaceutical and life sciences environments, ensuring compliance with regulatory requirements such as FDA, EMA, and ISO standards. This role is responsible for maintaining accurate documentation, managing document revisions, and ensuring proper control, accessibility, and traceability of quality-related records. Key Responsibilities: Organize and maintain controlled documents, including SOPs, batch records, protocols, and validation reports. Ensure compliance with Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) requirements. Review documents for accuracy, formatting, completeness, and version control. Support document lifecycle activities, including creation, revision, approval, distribution, and archival. Maintain document change histories, tracking logs, and audit trails. Assist with internal and external audits by retrieving and providing required documentation. Coordinate with QA, manufacturing, validation, and regulatory teams to support documentation activities. Maintain electronic document management systems (EDMS) and ensure proper document storage and retrieval. Preferred Skills: Familiarity with electronic document management systems (e.g., Veeva Vault, MasterControl). Basic understanding of 21 CFR Part 11 and electronic records requirements. Knowledge of data integrity principles, including ALCOA+. Basic proficiency in MS Office applications, including Word, Excel, and PowerPoint. Skills: Understanding of GMP documentation and document control procedures. Strong attention to detail, organizational skills, and accuracy. Basic knowledge of EDMS tools such as Veeva Vault and MasterControl is an advantage.