This is a fully remote position, open to applicants in Spain.

📋 Description

• Oversee and refresh QA trackers while facilitating the follow-up on quality events, including deviations, CAPAs, complaints, as well as associated actions and due dates.

• Coordinate with relevant stakeholders regarding pending actions, documentation, approvals, and quality-related inquiries.

• Assist in the transition of manual and legacy quality records into the Qualio eQMS, ensuring that all records are complete, precise, and well-organized.

• Aid in the continuous administration and upkeep of records within Qualio.

• Manage incoming requests through the QA inbox and direct them to the suitable QA team member when escalation or quality judgment is necessary.

• Facilitate routine training administration, which includes processing training requests, maintaining training-related records, and following up on outstanding tasks.

• Address or appropriately redirect common Qualio user inquiries and administrative requests.

• Assist with document and record management tasks, such as filing, naming, organizing, and maintaining controlled quality records.

• Help prepare quality metrics, status reports, and carry out routine QA follow-up activities as needed.

• Support various administrative and operational Quality Assurance tasks assigned by the Global Quality Assurance team.

⛳️ Requirements

• Approximately 1–2 years of experience in Quality Assurance, Quality Systems, document control, or a related field, ideally within the pharmaceutical, biotechnology, medical device, CRO, or other regulated life sciences sectors.

• Fundamental understanding of Quality Management System concepts and quality processes, including deviations, CAPAs, complaints, training, and controlled documentation.

• Previous experience with an electronic Quality Management System is a plus.

• Excellent organizational abilities to monitor multiple activities, deadlines, and follow-up actions.

• Keen attention to detail and a strong commitment to accurate recordkeeping.

• Strong written and verbal communication capabilities.

• Ability to work autonomously within established processes while appropriately escalating questions that require QA review or decision-making.

• Proficiency in English.