Quality Technician - GMP/ISO QA & Compliance

BD; Salamanca; On-site; EUR 24,000 - 36,000; Full time

Job summary

The Quality Technician role in Salamanca reports to the Quality Manager and supports design, manufacture, and release of clinical and research products to meet specifications. Responsibilities include environmental monitoring, validation, material disposition, CAPA, audits, and documentation in a regulated environment.

Minimum 1 year in a regulated industry with ISO 13485/ISO 9001 knowledge and GMP understanding; degree in Life Sciences preferred; strong English required.

Qualifications

• Requires a bachelor’s degree (preferred Life Sciences).
• 1 year of relevant experience in a regulated industry or equivalent education/experience.
• Knowledge of ISO 13485 and/or ISO 9001 standards.
• Knowledge of GMP.

Responsibilities

• Assure that Quality Notifications (QN) are created, investigated, completed and closed per SOPs.
• Identify quality events and support investigations.
• Support follow-up of complaints, changes, CAPAs, corrections and other quality records.
• Monitor, document and analyze Quality Metrics.
• Batch record QA review.

Skills

English proficiency

Education

Bachelor's degree in Life Sciences

Job description

The Quality Technician role in Salamanca reports to the Quality Manager and supports design, manufacture, and release of clinical and research products to meet specifications. Responsibilities include environmental monitoring, validation, material disposition, CAPA, audits, and documentation in a regulated environment.

Minimum 1 year in a regulated industry with ISO 13485/ISO 9001 knowledge and GMP understanding; degree in Life Sciences preferred; strong English required.