Quality Assurance Specialist, Operational Lead
Statistics & Data Corporation (Sdc)
Tempe , AZ 85281
Posted 6 months ago
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Provides daily oversight of SDCs quality management system and notifies applicable supervision/management of unauthorized deviations. This includes ensuring employees adhere with all standard operating procedures, as applicable to their individual roles. Actively participates in establishing quality goals and objectives and provides related input to business development and strategic planning, as required. Conducts detailed inquiries into quality related issues to develop lessons learned. Analyzes quality assurance related metrics for trends and improvement opportunities.
- Work with Operations to support projects by performing required Trial Master File (TMF) audits, identifying related risks and ensuring compliance to internal policies and procedures and external regulatory requirements.
- Provides technical / quality support to Operations project teams on a day-to-day basis.
- Identify potential impacts to project timelines proactively due to potential quality issues and / or TMF audits and reviews and works with necessary cross functional team(s) as appropriate to develop resolution plans and implement accordingly.
- Creation and tracking of lessons learned activities from TMF audits. Utilizes audit and quality review findings to assess and address any trends across studies.
- Participate in development of electronic tracking / filing systems in support of quality throughout TMF maintenance process.
- Participate in the development of TMF-related metrics to demonstrate compliance with TMF processes, TMF completeness, and inspection readiness.
- Investigates and responds to Corrective and Preventive Action (CAPA) and work with Operations to obtain evidence of deliverables and facilitates effectiveness checks as needed to ensure CAPA closure.
- Identifies areas of quality deficiency ensuring escalation to operational leadership and communication with appropriate QA staff. Participate in process improvement initiatives (as necessary), performing gap analysis and risk communication.
- Assists in development and modification of departmental work instructions and collaborates with appropriate Operations team to ensure departmental policies and procedures are kept current and are being adhered to.
- Act as a quality assurance liaison with internal and external cross-functional teams, clients, and suppliers, as required.
- Maintain thorough and current knowledge and understanding of GCP, ICH and other applicable regulatory requirements associated with the maintenance and retention of clinical trial documentation.
- Provide quality management system support during client and supplier meetings as needed.
- Perform other duties as assigned.
- Some experience in clinical research within a CRO environment is preferred.
- General aptitude in the art and science of quality assurance procedures and methods.
- Solid independent thinking ability and demonstrated ability to discern multiple viewpoints.
- Some knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations.
- Good analytical skills with the ability to evaluate data trends for lessons learned, required action, etc.
- Excellent verbal and written communication skills. The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Education or Equivalent Experience:
- Bachelors degree in applied or life science or engineering with advanced degree preferred or equivalent education and experience.
- Prior clinical trial experience is preferred.