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Supervisor, Document Control

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Job ID REQ_96301 FACILITY Rochester Regional Health Laboratories LOCATION Rochester, New York

SUMMARY

As a leader within the Quality Assurance team, the Supervisor, Document Control promotes and supports a culture of audit readiness within ACM Global Laboratories. Responsible for overseeing the Standard Operating Procedure (SOP) management process, including initial review and revision of SOPs within the electronic document control system globally. This role oversees a global team Document Control Specialists & Archivists; reports to the Sr. Director, Quality Assurance at our Rochester, NY site.

STATUS: Full Time

LOCATION: 160 Elmgrove Road, Rochester, NY

DEPARTMENT: Quality Assurance

SCHEDULE: Monday - Friday

ATTRIBUTES

  • Associates/Bachelor’s degree preferred.
  • 5 years of experience in quality control, quality assurance, document control, archival and/or a relevant role required; experience in a laboratory, pharmaceutical or Clinical Research Organization (CRO) preferred.
  • Knowledge of Document Control systems such as Master Control.
  • Knowledge of and demonstrated experience in Good Clinical Practice (GCP), ISO15189, NEQAS, CAP, CLIA strongly preferred.

RESPONSIBILITIES

  • Document Control. Manages the Standard Operating Procedure (SOP) process globally including review and revision of SOPs to support the Quality Management System (QMS) for ACM Global Laboratories. Serves as a resource for the operation promoting the development and understanding of QMS and regulatory compliance throughout the organization.
  • Reporting. Lead initiatives to ensure that the Document Control system supports the QMS needs of ACM Global Laboratory. Develop, monitor and report Key Performance Indicators (KPIs) to the organization.
  • Training. Maintain keen knowledge of all required standards, laws & guidelines to support quality assurance and regulatory compliance.
  • Leadership. Lead a team that partner strategically with site leadership to promote and support an ‘audit-ready, all the time’ culture.
Rochester Regional Health is an Equal Opportunity / Affirmative Action Employer. Minority/Female/Disability/Veteran
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