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Quality Assurance Specialist

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Job ID REQ_96303 FACILITY Rochester Regional Health Laboratories LOCATION Rochester, New York

SUMMARY

As a part of the Quality Assurance team, the Quality Assurance Specialist promotes and supports a culture of audit readiness within ACM Global Laboratories. Responsible for hosting customer audits & regulatory inspections, conducting internal audits, managing Quality Issue (QI) tracking, manages Corrective Actions & Preventive Actions (CAPA) and develops and maintains Standard Operating Procedures (SOPs). The Quality Assurance Specialist reports to the Director, Quality Assurance for our Rochester, NY site.


STATUS: Full Time

LOCATION: 160 Elmgrove Road, Rochester NY

DEPARTMENT: Quality Assurance

SCHEDULE: Monday - Friday


ATTRIBUTES

  • Bachelor’s degree required.
  • 3 years of quality assurance experience required; experience in a laboratory, pharmaceutical or Clinical Research Organization (CRO) preferred.
  • Knowledge of and demonstrated experience in Good Clinical Practice (GCP), ISO15189, NEQAS, CAP, CLIA strongly preferred.


RESPONSIBILITIES

  • Quality Assurance. Manage internal/external audits and regulatory inspections; support QI tracking and CAPA plans.
  • Process Improvement. Support the operation in process improvement initiatives; develop Standard Operating Procedures (SOPs) to support the QMS.
  • Training. Maintain keen knowledge of Good Clinical Practice (GCP) and appropriate regulatory standards to train and support the operation.
Rochester Regional Health is an Equal Opportunity / Affirmative Action Employer. Minority/Female/Disability/Veteran
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