QA Analyst

Dublin  ‐ Onsite
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Keywords

Description

A global CRO based in Dublin is seeking a Technical QA Analyst, the main function of the role is the execution and strategic reporting of technical quality assurance functions related to the analytical laboratory. Development of technical audit schedules and place, direct observation audits, formulating audit observations, partnering and debriefing with senior laboratory staff and approving corrective and preventive action plans. Also included is quality assurance oversight and assessment of technical related activities such as equipment commissioning. This position evaluates the regulatory compliance of technical requirements in the laboratory and works directly with senior QA management in ensuring that quality plans are in place to oversee the technical areas and proper implementation/ progression of improvement themes.

JOB FUNCTIONS & RESPONSIBILITIES
  • Travel (approximately >5%) domestic and/or international
  • Receives direction and priorities from Quality Assurance Management
  • Provides input based on risk analysis for audit schedules for technical areas (assay level ,director observation, process level)
  • Creates audit plans and conducts audits and created reports from audit activities
  • Assesses technical regulatory compliance and creates mitigations and enhancement plans in partnership with the laboratory management
  • Participate in client or regulatory audits
  • Oversees other compliance areas in the analytical areas- such as documentation practices, compliance with procedures, competency and equipment commissioning. All other duties as assigned.


EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS

  • A minimum of five years' experience working in a clinical laboratory in a medical technologist capacity. Laboratory supervisor/management experience preferred
  • A minimum of 2 years' experience working in quality assurance or other quality oversight
  • A high level of attention to detail.
  • Able to work in a high paced environment and willing to be open and forthcoming about issues and concerns.
  • Comfortable with interacting with all levels of management, effective communicator on risk situations.


EDUCATION
BS degree or higher in Biomedical science (clinical laboratory science) related field.

If you would like to hear more about this great opportunity and the company please contact me Anna Mooney or apply below with an up to date CV.
Start date
07/2014
From
Real Staffing
Published at
25.06.2014
Project ID:
731066
Contract type
Permanent
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