Quality Engineer(CAPA)

Job Title: CAPA Process Analyst II Location: Gretna, LA (onsite) Contract Duration: Contract until 11/10/2026 Working hours: 8:00 - 5:00 Total hours: 40 Description: Years Experience: 4+ Years The CAPA Process Analyst II: Conducts investigations of nonconformances/quality events and progresses the associated quality records through QMS platform in accordance with established procedures.

Collaborates with cross-functional teams to support investigations and ensure corrective actions are appropriate.

Ensures that corrective and preventive actions are appropriate, accurately and completely documented, implemented on time, and meet the required procedural and regulatory standards.

Interacts cross-functionally, 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 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.

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 Toxicology Laboratories' goals and objectives.

Performs other duties as assigned by the Quality Manager.

Required Qualifications: Bachelor's degree in Life Sciences 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 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 Participate in supplier quality and supplier corrective action process Improve supplier product and process quality Determine root cause and corrective actions Investigate root cause and corrective actions Resolve supplier quality related issues Manage corrective action and quality improvement activities Perform root cause analysis of product quality issues Determine root cause and corrective action plans Implement and verify corrective actions of supplier quality issues Resolving customer quality issues and driving root cause and corrective action on process and product quality issues Obtain corrective actions from suppliers Accomplish internal quality system audits Identify root cause analysis and establish corrective actions Manage the supplier corrective action report Conduct internal quality process and product audits Improve product quality and manufacturing processes Identify repeat quality issues by supplier and maintain supplier quality scorecard Assist supplier quality manager with supplier improvement process and/or development activities Lead or assist in root cause corrective actions Lead quality problem solving process for supplier related issues

Permanent