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QA Validation Specialist

  • Job type: Contract
  • Location: Daytona Beach
  • Salary: Competitive
  • Job reference: MK ValidationSp
  • Sector: Quality Assurance, EPM Scientific, Quality
  • Date posted: 29/01/2018
One of my large medical device clients is looking to expand their team and bring a QA Validation Specialist on board. This company prides themselves on being a front-runner in driving innovation and promoting sustainability.

The QA Validations specialist will be working in a team setting supporting Quality and Engineering for new products/equipment. The QA Validation specialist will work with a team to support QA Validation, execute, review and approve Validation Protocols and Reports. This individual with Investigate and write exception reports in validation and perform root cause analysis, investigation, and management.

Responsibilities:
-Implement PAT across different teams
-Lead and execute risk management/risk-based approaches
-Perform data analysis make educated guesses base on data
-Lead team meetings, tracking, and reporting. 
-Create and ensure work procedures for execution of proper validation


Requirements:
-Previous experience in Validation
-previous experience working in a regulated environment for medical device, biotech, or pharmaceutical
-5S, Root cause analysis, 6 Sigma Green Belt, Process Analytical Technology (PAT)
-Knowledge of the following:
     -21 CFR Parts 11, 210, 211, and 820
     -US FDA CDER 2011
     -EU guidelines for GMP- medical product for human an vet use
     -ICH guidelines for industry Q7
     -ASTM E2500, GAMP 5


If you are looking to join a team that promotes growth in career in the medical device industry, apply today! I look forward with you!



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