Quality Assurance Specialist
1 month ago
Job Title: CAPA Process Analyst/ Quality Assurance Specialist
Location: Gretna, LA 70053
Duration: 9 Months
The CAPA Process Analyst II:
- 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 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's 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
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