CAPA Process Analyst II job in San Diego, California
Vacancy has expired
San Diego, California CorTech LLC
| Job Ref: | 344434 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 46.10/Per Hour |
| Remote: | No |
Location |
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| City: | San Diego, California |
| Post Code: | 92121 |
| Map: |
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Description |
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CorTech is seeking to hire a CAPA Process Analyst for our client in San Diego, Ca! Benefits Available! Weekly Pay! $46.10/Hour Exempt/Non Exempt: Non-Exempt Years Experience: 4+ Years The CAPA Process Analyst II:- Progresses investigations and other activities through the CAPA program. - Leads cross-functional teams in the use of investigational tools to determine the root cause of nonconformities, ensures that CAPA plans address root causes, and that CA/PAs are implemented timely to facilitate the rapid and compliant introduction of new/improved products, processes, and systems. - Ensures that actions are on time, thorough, complete, and meet the needs of the business and customers, and that required standards and/or procedural requirements are met. - Leads a multifunctional team, 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 to ensure the timely completion of CAPA system activities raised for nonconformance's, potential nonconformance's, CAPAs, deviations, and/or complaint investigations. Is a subject matter expert on investigation and root cause analysis techniques to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance. Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area. Ensures all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner. Produces trending metrics and reports to identify, prioritize and manage further actions, as may be required. Provides leadership for the initiation of improvement activities associated with identified trends. Is an active leader supporting a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements. Ensures effective written and verbal communications. Prioritizes workload in relation to the needs of the business. Supports the attainment of Client Hematology goals and objectives. Prerequisite skills Knowledge of the Corrective and Preventative Action process in medical devices Understanding of statistics Experience with medical devices which have reagents, complex electro-mechanical and optical components. Bachelor of Science in a life science or engineering discipline 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 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 | |
ref: (344434)
1062 days ago
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