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QA Validation Specialist III (Medical Device)

  • Job type: Permanent
  • Location: Daytona Beach, Florida
  • Salary: Competitive
  • Job reference: 175381/005_1529012830
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 14/06/2018

QA Validation Specialist III (Medical Device)

An forward-thinking global Medical Device company is seeking a QA Validation Specialist III to join their growing team at their location in the greater Daytona, FL area! This company is market leader in infusion therapy and pain management. They strive to continuously improve their therapies and lower costs by sharing knowledge with their clinicians, patients and partners. If you are looking to expand your career in quality with an industry leader in infusion therapy don't hesitate to apply!

The Quality Assurance Validation Specialist will have the following responsibilities:

This individual will provide Quality Assurance support for validation activities associated with equipment, processes, facilities, and computer software/systems to ensure compliance with applicable current Good Manufacturing Practice (GMP) regulations, corporate policies, and site Standard Operating Procedures (SOP). Work closely with the various departments in the design and development of validation protocols to ensure the purpose, testing and intended outcomes are defined and are in compliance with the Master Validation Plan and applicable GMP and regulatory requirements.

  • Ability to read/interpret validation and engineering documents (protocols and reports).

  • Ability to interpret and relate Validation standards for implementation and review of functional areas.

  • Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements.

  • Review Change Controls, Incidents, Investigations, CAPAs, SOPs.


The ideal candidate will have the following skill set:

  • Bachelor's degree (B.A. / B.S.) in a scientific or engineering discipline.

  • 3 years QA validation experience in the pharmaceutical industry in a cGMP setting.

  • Hands on oral solid dosage validation experience.

  • Sterile Process Validation experience

  • Doc Review experience( summary reports, protocols, change controls, investigations, CAPA's)

Compensation:

Competitive base salary + Full Medical Benefits + Relocation for the right candidate

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