Cynet Systems Inc
Senior Quality Associate
PayCompetitive
LocationValencia/California
Employment typeFull-Time
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Job Description
- Req#: 25-31015
- Maintains the QA database(s) ensuring Audits when identified are entered onto the system from audit plans/notification documentation and that the system is updated as required.
- Audit information is followed up as required, through the full audit life cycle including: Missing Information relating to the planned audits are identified, gathered and entered. Performed audits are confirmed.
- The full text of audit findings are entered onto the database from Sponsor/Regulatory audit reports.
- Follow-up of Reports and Corrective And Preventive Actions and Follow-up of overdue Critical/Major findings.
- Certificates and contracted audit documentation are issued and distributed as appropriate.
- Provide support to staff by answering more complex queries concerning the use of EDA.
- Participate in systems validation process (such as User Acceptance Testing) as required.
- Review and track documentation related to the Global QA auditing lifecycle (Internal, External.
- Contracted customer audits regulatory inspections, and Regulatory Audits, Quality Issues, Corrective And Preventive Actions and status of Critical / Major issues).
- Maintains the system to track audit plans ensuring that signed audit plans are tracked, received and distributed.
- Maintains the QA filing systems for audits including electronic filing of documentation and correspondence.
- Produce documentation from the QA databases, including status reports of overdue information, tables and graphs, and reports illustrating overall trends for missing or overdue date entry requirements as required.
- Use metrics to optimize performance, productivity, and effectiveness of the processes and systems.
- Participate in the development and provide training on new/enhanced QA database maintenance processes including providing training to new users involved in QA database maintenance.
- Keep current in advances in area of expertise, including regulatory knowledge, trends, and developments, including complying with all required SOPs and timelines.
- Following up and Closing audits/Inspection Corrective and preventive actions (CAPA) in the eQMS.
- Review and approval of Corrective and preventive actions (CAPA) and Effectiveness check (EC) plans.
- Categorizing audit/Inspection findings in the eQMS.
- May participate in audit hosting.
Job Description:
Pay Range: $30.68hr - $35.68hr
Essential Functions:About the company
We are a team of technical visionaries who joined forces to form a company that would gather the best and brightest talent in the world. The company uses this talent to help other organizations fulfill their technological dreams and goals and make them a reality. Welcome to Cynet Systems Inc. – a premier staffing and recruiting company – a nationally and locally certified diversity firm.