Years Experience: 4+ Years
The CAPA Process Analyst II:
- Conducts investigations of nonconformances/quality events and progresses the associated quality records through Client s 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 Client 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 Client 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
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.