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CAPA Analyst Location: US-CA-San Diego Email this job to a friend
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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. - 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 reflect 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
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: - 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.
- Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic.
- Knowledge of MS Office.
- Excellent organization skills must be able to manage a large number of simultaneous projects
- Attention to detail must have precision in their work, especially as it relates to understanding and documenting complex quality issues
- 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.
- Effective interpersonal skills Work with peers throughout the organization and be effective in engaging resources throughout the organization
- Excellent critical analytical skills ability to find root cause of why an issue occurred.
- Ability to review action plans and determine if the actions taken effectively address the issue
Intellectt INC
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