Negotiable
Inside
Hybrid
London Area, United Kingdom
Summary: The Quality Assurance Coordinator role at Vertex Pharmaceuticals is a 6-month contract position focused on coordinating various quality assurance activities within the department. The position involves managing records in electronic systems, supporting QA processes, and assisting in audits and inspections. The role requires effective communication and organizational skills to manage multiple projects and tasks. This position is classified as inside IR35 and is hybrid, requiring three days on-site in Paddington, London.
Key Responsibilities:
- Coordinate quality system oversight for team meetings, generating system queries, meeting minutes, and following up on actions.
- Manage records in electronic quality management systems (eQMS) or electronic document management systems (eDMS), including data entry, tracking, and follow-ups.
- Assist QA personnel and system owners in designing and delivering analyses, metrics, and KPI dashboards.
- Support day-to-day QMS processes, QA process improvement projects, inspection readiness, and development of SOPs, procedures, and reports.
- Perform archival of QA records in eDMS and maintain files for easy retrieval.
- Coordinate document approvals and create Docusign workflows as necessary.
- Participate in special projects and system implementations to improve data analysis and reporting capabilities.
- Support weekly/monthly/quarterly Quality System data review metrics and reporting.
- Assist in preparation for quality audits and participate in internal audits and external inspections.
- Perform administrative functions for larger project teams and departments.
- Multi-task to manage efforts on multiple projects effectively.
- Communicate proactively with internal and external partners and management.
Key Skills:
- 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, and reporting.
- Effective communication skills, both verbally and in writing.
- Critical thinking and problem-solving skills.
- Working knowledge of Microsoft Office products (Word, Excel, PowerPoint, Outlook).
- Attention to detail, flexibility, and ability to manage multiple activities to deadlines.
- Good organizational/planning and coordination skills.
Salary (Rate): undetermined
City: London
Country: United Kingdom
Working Arrangements: hybrid
IR35 Status: inside IR35
Seniority Level: undetermined
Industry: Other
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.
Experience Required:
- 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.
Vertex is partnering with Talent Works to manage their international temporary job openings. If you are successful in your application, you will be employed by Talent Works to work on a temporary assignment at Vertex.