What are the responsibilities and job description for the CAPA Process Analyst II position at GTT, LLC?
Overview
Title: CAPA Process Analyst II
Location: Gretna, LA
Shift: 5 x 8 hour Days
Duration: 13 weeks
Pay: $32/hour
Required Qualifications:
- 4 years of experience
- Bachelor's degree in Life Sciences
- Experience with the Corrective and Preventive Action process in regulated environments, pharmaceuticals, medical devices, or laboratoriesExcellent communication and technical writing skillsExperienced in working with QMS platforms
Preferred Qualifications:
- ASQ CQA
- Project management experience
- Knowledge of College of American Pathologists (CAP) regulations, NLCP regulations, or similar regulations (i.e., FDA).
- Experienced in navigating Agile
Duties
- Leads the investigation of complex and highly technical quality issues and ensures the timely completion of CAPA system activities initiated to address nonconformances, potential nonconformances, deviations, and/or complaints.
- Executes investigations and CAPAs in accordance with established procedures, ensuring consistency with quality system requirements.
- Serves as a subject matter expert in conducting investigations and performing root cause analysis to ensure that root and potential causes are appropriately identified and mitigated/eliminated.
- Collaborates with laboratory operations and technical staff to conduct investigations and ensure corrective actions are appropriate and effectively implemented.
- Maintains CAPA system records to ensure audit-readiness for internal and external quality system audits.Ensure CAPA documentation is accurate, well-structured, and compliant with procedural requirements and regulatory guidelines.
Pay: $31.00 - $32.00 per hour
Benefits:
- Dental insurance
- Health insurance
Experience:
- CAPA Process Analyst II: 2 years (Required)
- CAPA: 2 years (Required)
Work Location: On the road
Salary : $31 - $32