Multiple Locations: San Antonio, Texas, United States • Florida, United States • Nevada, United States • Oklahoma, United States
Requisition Number: 1183
Position Title: Document Coordinator
This is a contract position scheduled to last until the end of 2020. This can be a remote position, however, there are no benefits and this will be a 1099 position.
SUMMARY: The Document Control Coordinator, Process Management, is responsible for supporting the development and maintenance of GxP Quality Management Documents (QMDs) and Worldwide’s Quality Management System (QMS). The individual performs document control activities, develops tools, and ensures consistency and compliance with applicable standards. The individual assists Process Owners and functional collaborators with procedural document development in alignment with Worldwide’s procedures for QMD lifecycle management.
Tasks may include but are not limited to:
- Serves as a champion of Worldwide’s QMS by participating and encouraging a strong quality culture
- Performs document control activities throughout the GxP QMD lifecycle, including but not limited to supporting the development, deployment, revision, retirement, archiving of QMDs
- Supports tracking, and reporting of metrics for the document control and internal compliance functions
- Contributes to preparation for the QMD Governance Committee (QMD-GC) meeting; could be assigned administrative duties regarding QMD-GC quorum management, minutes and archiving
- Assists with the maintenance of the QMD Master Index, SOP Master Index, eQMS data entry, QMD deviation routing, tracking and archiving, and with other QMD management trackers and tools
- Supports the process for external dissemination of Worldwide’s QMDs
- Collaborates with internal stakeholders to ensure compliance with the QMS and QMD lifecycle procedures
- Executes individual goals for and supports team objectives of the QA document control organization
- May participate in other departmental or cross-functional initiatives, as assigned
- Perform other duties as assigned
- The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- Communicates professionally, effectively, clearly and consistently, both verbally and in writing
- Demonstrates a client-focused approach to work
- Demonstrates critical thinking skills and ability to appropriately triage requests and concerns and escalate them
- Demonstrates a detail-oriented work style, following requests and assignments to closure
- Demonstrates a courteous, results-oriented commitment to build positive work relationships
- Manages workload priorities and keeps supervision informed of challenges and availability
- Works with a sense of urgency, recognizing and delivering time-sensitive deliverables by deadlines
- Works with limited supervision and has a flexible approach to work assignments
- Provides constructive input on processes and adapts to organizational changes
- Ability to read, write and speak fluently and correct English required
- Experience managing procedural documents, such as SOPs, forms, and templates, within last 2 years required
- Strong Microsoft application skills, including in Excel, Outlook, PowerPoint, and SharePoint required
- Excellent Microsoft Word skills, including building and formatting forms, templates and related documents
- Strong organizational and time management skills required
- Experience with electronic Quality Management Systems (eQMS) an asset
- Working knowledge of GxP regulations preferred
- Associates degree preferred; 3+ years of document control experience in a related field or project coordination
Employment Type: Contractor
Community / Marketing Title: Document Coordinator
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: San Antonio, Texas US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.