Quality Assurance Specialist

hace 3 días


Salamanca, Salamanca, España Becton Dickinson A tiempo completo
Job Title: Quality Assurance Specialist

About the Role:

The Quality Assurance Specialist will participate in activities supporting the design, manufacture, and release of clinical and research products that meet established specifications. These activities include environmental monitoring, validation, material disposition, in-process product disposition, finished goods' disposition, data collection/trend analysis, quality auditing, Quality/Compliance Training, CAPA, complaint processing & investigation, quality record retention, quality documentation, and change control process.

Main Responsibilities:

  • Assure that Quality Notifications (QN) are crafted, investigated, completed, and closed in accordance with the established Standard Operating Procedures.
  • Identify quality events and support investigations.
  • Report quality issues to the Quality Manager.
  • Support other associates or departments in the accurate follow-up, documentation, and completion of complaints, changes, CAPAs, corrections, and records.
  • Monitor, document, and analyze Quality Metrics.
  • Batch Record QA review.
  • Capture information for the Quality Management Reviews, for the preparation of reports, and other department activities.
  • Draft and update local SOPs or working instructions, analysis reports, plans, and other quality documents.
  • Support the Quality department in audits (external, internal, and customer) and other investigations from regulatory agencies, Notified Bodies, and customers.
  • Act as a role model for Quality by daily representation of all quality aspects and modeling and emphasizing quality in the workplace.
  • Keep abreast of basic requirements for compliance and align with those requirements.
  • Participate as required in training on regulatory issues affecting own area of work.
  • Bring regulatory compliance questions/issues to the attention of management.
  • Provide recommendations to support systems that continuously improve product/process quality and product availability, reduce cost, and increase production capability.

Requirements:

  • Bachelor's degree or equivalent experience (preferred Life Sciences)
  • 1 year relevant technical experience in a regulated industry or a combination of equivalent education and experience
  • Experience with ISO 13485 and/or ISO 9001 standards
  • Knowledge of Good Manufacturing Practices (GMP)
  • Upper intermediate Level of English

Salary Information:

We estimate the salary for this position to be around $60,000-$80,000 per year, depending on location and experience.



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