Quality Assurance Specialist

Descripción del empleo

Kapadi is a full service CRO that focuses on complex oncology indications including immunotherapy and cellular therapies. We know that innovative research requires innovative operations and we've built that into our culture, systems and processes. We have an infrastructure to enhance access to patients and integrated technology to provide higher quality and faster access to results. We are looking for a highly-motivated Quality Assurance Specialist to help us continue to grow our business.

The Role

To support the Quality Assurance department (Maintenance of QMS documents) & Training Records. To collaborate with the Quality Assurance team to ensure that the different departments meet the quality standards and collaborate in the audits contracted by suppliers and internal auditors. All this under the established standards in terms of SOPs, Good Clinical Practice and the needs of the client

Key Responsibilities

• Provide advice, interpretation, help and training to other departments, in GCP, SOPs, regulatory issues and internal company policies related to Quality Assurance
• Participate in the review and follow-up of corrective action plans for internal compliance, Data Protection, audits and regulatory inspections
• Help the Quality Assurance team in the proposals for revision and communication of the corrective/preventive measures of Quality Assurance
• Maintain the databases and electronic file systems for Quality Assurance
• Create, update and collect SOPs, templates and forms/documents
• Follow up on compliance with the times and manner of the employees in terms of revision, signature or training on issues of Quality Assurance
• Support the Quality Assurance manager with the coordination of audits (external by clients or inspections and internal audits or internal Vendor Qualifications management). Assist in audit preparing activities such as Quality Assurance Administrative Tasks (Agenda, audit plan), readiness of the QMS data, data collection, follow up activities and assisting other departments
• Assist the Quality Assurance Department with completing all required tasks to meet departmental and project goals e.g.: planned audit reports, Controlled Documents targets, preparation of quality metrics and annual reports; overdue response, training compliance, scheduling/maintaining calendar, email correspondence, etc
• Support Quality Assurance, IT and DM in the validation activities (document review, filing, uploading in the system and approval)
• Any other reasonable task that derives from the previous ones or the position requires

Your Profile

• Bachelor’s degree in health sciences or equivalent preferred
• 1-3 Years of research related experience in Quality Assurance, pharmaceutical, biotechnology, or related industry
• Fluent English

What We Value

• Knowledge, experience or certification of GCP, ICH, GDPR or other applicable regulations
• Good computer skills (MS office applications)

What We Offer

• Fully remote role
• Opportunity to build and scale a global function
• Global and collaborative environment

Información extra

Status

Activa

Estudios requeridos

E.S.O

Localización

Valencia

Tipo de contrato

Trabajo estudiantes

Publicado el

03-06-2026

Carnet de conducir

No

Vehículo

No

Carta de motivación

No

Idiomas

Español