QA Audit Associate

Cynet Systems
24 Apr 2019
25 Apr 2019
Job role
Contract type
Full time
We are looking for QA Audit Associate for our client in Valencia, CA Job Title QA Audit Associate Job Location Valencia, CA Job Type Contract US citizens and those authorized to work in the US are encouraged to apply. We are unable to sponsor H1b candidates at this time. Job Description RESPONSIBILITIES Maintain the QA database(s) ensuring that Audits when identified are entered onto the system from audit plansnotification documentation 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 is identified, obtained and entered into the system Confirmation of audits performed Follow–up of Report issuance Follow–up until Corrective And Preventive Actions agreed Follow–up of overdue CriticalMajor findings The full text of findings are entered onto the database from SponsorRegulatory audit reports Ensure that certificates are issued and distributed as required. Provide support to staff by answering simple queries concerning the use of EDA Ensure Contracted Audit Documentation is distributed as specified in the audit plan Review and track documentation related to the Global QA auditing lifecycle (Internal, External, Contracted and Customer Audits, Regulatory Inspections Quality Issues, Corrective And Preventive Action and status of Critical Major issues) Produce documentation from the QA databases, including status reports of overdue information, tables and graphs as required Maintain the QA filing systems for audit lifecycle tracking, including electronic filing of documentation and correspondence Provide timely feedback to line management on audit lifecycle system status as appropriate REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Ability to utilize Microsoft Office software, including Word and Excel Ability to utilize electronic data management software Ability to review, approve, and publish electronic records Excellent English written and verbal communication skills Ability to establish and maintain effective working relationships with coworkers, managers and customers. Positive interaction skills, attention to detail, and organizational skills Good problem solving skills Ability to handle multiple tasks and to follow through with completion of assigned tasks with supervision Ability to learn scientific, medical, and regulatory terminology to gain an understanding of Quality data and fields in QA database(s) to be able to translate data user requests for information into specific queries required to independently generate requested metrics MINIMUM REQUIRED EDUCATION AND EXPERIENCE High School diploma and 3 year s experience or equivalent combination of education, training and experience. PHYSICAL REQUIREMENTS Extensive use of keyboard requiring repetitive motion of fingers Extensive use of telephone and face–to–face communication requiring accurate perception of speech. Regular sitting for extended periods of time