CAPA Process Analyst in Gretna, LA

  • Title: CAPA Process Analyst
  • Code: RCI-36353
  • RequirementID: 119380
  • Location: Gretna, LA 70053
  • Posted Date: 07/10/2024
  • Duration: 7 Months
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  Job Description

Years Experience:

  • 4+ Years

Duties:

  • Progresses investigations and other activities through the CAPA program.
  • Leads cross-functional teams in the use of investigational tools to determine the root cause of nonconformities, ensures that CAPA plans address root causes, and that CA/PAs are implemented timely to facilitate the rapid and compliant introduction of new/improved products, processes, and systems.
  • Ensures that actions are on time, thorough, complete, and meet the needs of the business and customers, and that required standards and/or procedural requirements are met.
  • Leads a multifunctional team, ensuring that all communications, interpersonal interactions, and business behaviors are consistent with the Client Code of Conduct.

 

Main Responsibilities:

  • Leads the investigation of complex and highly technical quality issues to ensure the timely completion of CAPA system activities raised for nonconformances, potential nonconformances, CAPAs, deviations, and/or complaint investigations.
  • Is a subject matter expert on investigation and root cause analysis techniques to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance.
  • Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
  • Ensures all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.
  • Produces trending metrics and reports to identify, prioritize and manage further actions, as may be required.
  • Provides leadership for the initiation of improvement activities associated with identified trends.
  • Is an active leader supporting a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements.
  • Ensures effective written and verbal communications.
  • Prioritizes workload in relation to the needs of the business.
  • Supports the attainment of Client Toxicology Laboratories goals and objectives.
  • Ensures compliance to organizational procedure, regulatory requirements and industry standards and timely completion of CAPAs and audit findings.

 

Required Qualifications:

  • Bachelor’s degree in engineering or Life Sciences
  • Experience with Corrective and Preventative Action process in medical devices or laboratories
  • Excellent communication and technical writing skills

 

Preferred Qualifications:

  • Understanding of statistics, FMEA and a ASQ CQE
  • Knowledge of Quality requirements within Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP) regulations or similar regulated industry.

 



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