Quality Assurance Specialist - Remote

Quality Assurance Specialist - Remote

28 Feb 2024
North Carolina, Raleigh / durham / CH, 27601 Raleigh / durham / CH USA

Quality Assurance Specialist - Remote

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Job Description

  • Ensure company compliance with GxP requirements, company policies and procedures, ISO standards, and MDD/MDR requirements
  • Interpret and comply with quality assurance standards
  • Ensure adequacy of current quality assurance standards and recommend enhancements
  • Document quality assurance activities, including, internal audits and CAPAs
  • Support other departments with CAPA process, including, creation and follow through to completion, ensuring appropriate documentation is captured
  • Analyze non-compliance issues to identify trends and propose resolutions
  • Gather and organize statistical quality data
  • Identify quality areas for improvement
  • Report on results of quality activities
  • Carry out appropriate corrective procedures from internal and external audits
  • Ensure risk management procedures are utilized correctly
  • Ensure ongoing abidance by industry regulatory and quality requirements
  • Other duties as assigned

Qualifications

  • 3+ years of experience in a quality role or a combination of education and experience
  • Experience working in a quality capacity (pharmaceutical or medical device preferred)
  • Experience working in an ISO environment (preferred)
  • Ability to handle sensitive information with the highest degree of integrity, discretion and confidentiality
  • Analytical, problem-solving, and decision-making skills
  • Comfort working across teams in a fast-paced environment

Additional Information

All your information will be kept confidential according to EEO guidelines.

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