Capa Analyst Jobs

Role: CAPA Process Analyst II
Location: San Diego, CA - 92121
Duration: 12 Months on W2
Shift Timings: 8 AM to 5 PM
Responsibilities
CAPA Administration Responsible for ensuring CAPA system is being managed effectively.

• Ensure that CAPA records are complete and they contain accurate links and references to other Quality processes such as Change Management, Non-Conformance, and Complaint Handling.
• Provide ongoing support to Quality management during external audits.
• Manage the archival and handling of scanned CAPA records.
• Other duties as assigned, according to the changing needs of the business
• Support and guide the Corrective Action Review Board and Users regarding the CAPA process, CAPA record content, and CAPA software.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and
• Critical Review of documents. Experience in assessing the weight of evidence associated with a claim/hypothesis/assertion is preferred.
• Support the development, implementation and continuous improvement of Quality System CAPA procedures, CAPA software, and CAPA training.
• Validation, manufacturing, and testing activities
• Demonstrates commitment to the development, implementation, and effectiveness of ARDx Quality Management System per ISO, FDA, and other regulatory agencies.
• Carries out duties in compliance with established business policies
• Ensure implementation, and effectiveness verification of CAPA and participate in remediation of legacy CAPA files.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflect positively on the company and is consistent with the company's policies and practices; build productive internal/external working relationships
• Provide site administration of the CAPA program and support process owners in completing CAPAs and related business items.

Supervisory Responsibilities
Minimum qualifications

• Bachelor's degree, or the equivalent 1-2 years' experience in a FDA-controlled environment.

Preferred Qualifications
Preferred educational background:
Bachelor's degree in a related technical field is preferred but not required.
Preferred Experiential Background

• Excellent organization skills must be able to manage a large number of simultaneous projects
• Ability to review action plans and determine if the actions taken effectively address the issue
• Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic.
• Excellent writing skills must be able to summarize complex issues in a clear, succinct, and accurate manner. Must be able to write in a manner that effectively conveys complex issues to the reader.
• One to two years' experience working in a professional environment where compliance was of vital importance.
• Knowledge of the QSR or ISO 13485 is a plus.
• Attention to detail must have precision in their work, especially as it relates to understanding and documenting complex quality issues
• Excellent critical analytical skills ability to find root cause of why an issue occurred.
• Knowledge of MS Office.
• Effective interpersonal skills Work with peers throughout the organization and be effective in engaging resources throughout the organization