Quality Assurance Coordinator, 6-month contract
Vertex Pharmaceuticals
Type of Role: Contract position, Inside IR35
Contract length: 6 months
Location: Hybrid, 3 days on site in Paddington, London

Looking for opportunities with purpose, impact and possibilities? Our client, Vertex, is a global biotechnology company that invests in scientific innovation. As they grow their pipeline at pace, they are strengthening their reputation for creating transformative medicines for people with serious diseases.

General Summary:
The Quality Assurance Coordinator will be responsible for a wide variety of coordination activities within the department. Activities typically consist of well-defined support tasks that are performed independently as well as projects of increased complexity completed under close supervision.

Key Duties and Responsibilities:

• Coordinate quality system oversight for team meetings, generating of system queries, meeting minutes, and following up on actions.
• Manages records in electronic quality management systems (eQMS) or electronic document management systems (eDMS), including data entry, tracking, and follow-ups with Owners to drive completion.
• Assist QA personnel and system owners in the design and delivery of analyses, metrics and KPI dashboards to allow real-time assessment of system compliance and to inform decision making.
• Support in day-to-day QMS processes, QA process improvement projects, inspection readiness and the development of SOPs, procedures and reports.
• Performs Archival of QA Records in eDMS (e.g., CMO batch records, data packages).
• Maintain files such that documents are readily available and easily retrievable.
• Coordinates document approvals and create Docusign workflows, as necessary.
• Participate on special projects and system implementations to ensure continuity and improvement in data analysis and reporting capabilities.
• Support in the creation of dashboards, reports and any necessary data analysis / manipulations.
• Support weekly/monthly/quarterly Quality System data review metrics and reporting.
• Assist the facility in preparation for quality audits and participate in internal audits and external inspections, as needed.
• Performs administrative functions for larger project teams and departments.
• Multi-tasks to effectively manage own efforts on multiple projects.
• Troubleshoots routine problems.
• Tracks materials needed for project execution.
• Adherence to tasks, commitments and deadlines provided by management and leadership.
• Communicates proactively with internal and external partners and management.

• Bachelor’s degree in a scientific or related field
• Experience in managing and archiving records in electronic quality management systems (eQMS)
• Experience in general QA related activities, process improvement, coordination, reporting.
• Works well both independently and in a team setting.
• Effective communication skills, both verbally and in writing.
• Critical thinking and problem-solving skills.
• Possesses working knowledge of Microsoft office products (Word, Excel, Power Point, Outlook).
• Demonstrates attention to detail, flexibility, and ability to manage multiple activities to expected deadlines.
• Good organizational/planning and coordination skills.