Quality Assurance Specialist

13 hours ago


Reston, Virginia, United States Commonwealth Sciences, Inc. Full time

Quality Assurance Specialist

About the Role:

We are seeking a highly skilled Quality Assurance Specialist to join our team at Commonwealth Sciences, Inc. in Rochester, MN. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and integrity of our laboratory data and processes.

Key Responsibilities:

  • Develop and implement QA strategies to ensure compliance with GxP regulations and company standards.
  • Perform audits on raw data and final reports to ensure accuracy and compliance.
  • Monitor laboratory quality assurance activities to determine conformance with policies and procedures.
  • Review documentation for adherence to quality standards.
  • Ensure facilities, equipment, and processes comply with regulations and company standards.
  • Provide QA support for change controls, deviations, investigations, and CAPA's.
  • Develop and maintain compliance-related metrics and reports.
  • Make recommendations for correction and improvement as necessary.
  • Provide oversight of personnel training record management.
  • Support internal and external audits as assigned.
  • Review and update Quality Assurance procedures.
  • Maintain audit forms and QA records.

Requirements:

  • Bachelor's degree in quality assurance or science-related field.
  • Minimum of 5 years in GxP or equivalent regulatory environment.
  • Excellent knowledge of GLP and GCP requirements.
  • Working knowledge of ISO 9001, ISO 17025, and ISO 17034.
  • Experience with reviewing laboratory data and computer-validated data collection systems.
  • Able to understand published methodology to audit existing test methods.
  • Thorough understanding of governing regulations and scientific literature.
  • Experience performing quality process audits and reviewing deviations and CAPA.
  • Solid working knowledge of Microsoft Office software.
  • Possess excellent time and project management skills.
  • Possess excellent interpersonal and communication skills.
  • Background in molecular biology, virology, and/or serology is a plus.
  • CRO experience is a plus.
  • Experience with eQMS (Qualio) is a plus.


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