Document Specialist Consultant
215 First St, Cambridge, MA 02142 Cambridge, MA 02142 US
Searching for a creative, resourceful, integrative thinker for an important role as a Document Specialist Consultant, responsible for organizing the life cycle of documents in the electronic Document Management System as well as maintaining the Quality Systems archive of records, stored both onsite and offsite.
Roles and Responsibilities Maintain logs and document inventories to ensure chain of custody traceability. Oversee upload of records into the electronic Document Management System (eDMS) in compliance with regulatory requirements. Support program efforts for Certified Copy creation, which may include scanning and reviewing the replica based on established standards. Maintain inventory and indices of onsite and offsite GxP documents and records. Provide support during internal and external audits related to Regulatory and internal audits for Documentation. Perform additional responsibilities assigned by manager.
Experience, Education and Specialized Knowledge and Skills Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. The individual will need to be able to effectively communicate with various stakeholders and Quality Assurance team members at varying levels throughout the organization. The Document Specialist will need excellent organizational skills, attention to detail, diligence, and flexibility as well as be able to prioritize responsibilities and adhere to deadlines.
Basic Qualifications Bachelor’s degree with 1+ years of applicable experience either in pharmaceutical drug development/life sciences/biotechnology and/or records and archive management. Outstanding communication skills (interpersonal, verbal, and written) and collaboration skills. Proficient with using MS Office (e.g., Word, PowerPoint, Excel). Must be able to lift 25 lbs. Must be willing to work onsite 4 days a week. Preferred Qualifications Expertise with Microsoft and Adobe products (e.g., SharePoint, Visio, and Acrobat Pro). Experience with working in an electronic Document Management System, including Veeva Vault Quality Docs. Experience with quality systems and activities at all phases of the Product Lifecycle and knowledge of GxP regulations, particularly pertaining to quality systems requirements. Experience building relationships and working with internal and external stakeholders. Detail oriented and self-motivated.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.