CAPA Process Analyst

CAPA Process Analyst II

Location: Gretna, LA

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 13 months
• Pay Rate: $33.65 / Hour (USD)
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

This role conducts investigations of nonconformances/quality events and progresses the associated quality records through the client's QMS platform in accordance with established procedures. The analyst collaborates with cross-functional teams to support investigations and ensure corrective actions are appropriate. The position ensures that corrective and preventive actions are appropriate, accurately and completely documented, implemented on time, and meet the required procedural and regulatory standards. The role also interacts cross-functionally, ensuring that all communications, interpersonal interactions, and business behaviors are consistent with the Client Code of Conduct.

Key Responsibilities

• 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.
• Ensures CAPA documentation is accurate, well-structured, and compliant with procedural requirements and regulatory guidelines.
• Supports the initiation and implementation of improvement activities associated with identified trends.
• Escalates potential compliance risks, quality concerns, or procedural gaps to the Quality Manager to ensure timely evaluation and resolution.
• Demonstrates effective written and verbal communication skills.
• Prioritizes workload in relation to business needs.
• Supports the attainment of client Toxicology Laboratories' goals and objectives.
• Performs other duties as assigned by the Quality Manager.

Required Skills

• Experience with Corrective and Preventative Action process in regulated environments, pharmaceuticals, medical devices, or laboratories
• Excellent communication and technical writing skills
• Experienced in working with QMS platforms
• Must be able to use EQMS

Preferred Skills

• ASQ CQA certification
• Project management experience
• Knowledge of College of American Pathologists (CAP) regulations, NLCP regulations, or similar regulations (i.e., FDA)
• Experienced in navigating Agile

Education Requirements

• Bachelor's degree in Life Sciences required

Required Experience

• 4 years of experience
• Experience with Corrective and Preventative Action (CAPA) process in regulated environments, pharmaceuticals, medical devices, or laboratories

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

About the Client

This leading healthcare innovator has dedicated more than 140 years to improving lives worldwide, operating across more than 160 countries through a diverse portfolio of medical devices, diagnostics, nutritional science, and pharmaceutical products. The organization employs biomedical engineers, clinical scientists, regulatory affairs specialists, and commercial operations professionals across four major business segments medical devices, nutritional products, diagnostics, and established pharmaceuticals and is a certified Great Place to Work, with 80 percent of employees reporting it is a great place to work, well above the national average.

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-08363

Industry: Data & Analytics