|
Search Jobvertise Jobs
|
Jobvertise
|
CAPA Process Analyst Location: US-CA-San Diego Email this job to a friend
Report this Job
Greetings, kindly have a look at the below job description and try to share with me your updated resumes at larry@intellectt.com Role: CAPA Process Analyst Location: San Diego, CA Job Responsibilities: - Provide site administration of the CAPA program and support process owners in completing CAPAs and related business items.
- Support and guide the Corrective Action Review Board and Users regarding the CAPA process, CAPA record content, and CAPA software.
- Support the development, implementation and continuous improvement of Quality System CAPA procedures, CAPA software, and CAPA training.
- Ensure implementation, and effectiveness verification of CAPA and participate in remediation of legacy CAPA files.
- 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.
- Manage the archival and handling of scanned CAPA records.
- Critical Review of documents. Experience in assessing the weight of evidence associated with a claim/hypothesis/assertion is preferred.
- Demonstrates commitment to the development, implementation and effectiveness of ARDx Quality Management System per ISO, FDA, and other regulatory agencies.
- Provide ongoing support to Quality management during external audits.
- 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 validation, manufacturing and testing activities.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices; build productive internal/external working relationships.
- Carries out duties in compliance with established business policies.
- Other duties as assigned, according to the changing needs of the business.
Intellectt INC
|