Associate Quality Assurance Auditor - United States
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- Communicate all identified compliance and quality risks to supervisor.
- Assist auditors with data audits to assess that the records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures.
- Assist auditors with the review of SOPs, protocols/batch records, reports, and other quality and regulated records for accuracy and compliance with all applicable regulations, international standards, and corporate policies and procedures.
- Prepare written and signed records of all audits and inspections as required and may sign records as a trainee, countersigned by supervisor/trainer, documenting the performance of audits and inspections and reporting to management.
- Assist auditors with preparation for sponsor site visits and the review of QA files; assure that QA audit files are retained.
- Assist auditors in identifying, documenting, reporting deviations from regulations, protocols/batch records, SOPs, and specifications.
- Perform a preliminary review of protocols/batch records and reports to assure accuracy, completeness, and compliance with regulations, international standards, and company policies and procedures.
- Assist auditors with routine monitoring of processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with regulations and international standards.
- Perform all other related duties as assigned.
- Education: Bachelor’s degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline.
- Experience: 0-1 year experience (this is an entry-level/training position).
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Certification/Licensure: None.
- Other: Knowledge of Microsoft Office applications (e.g. Word, Access, Excel). Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements. Must be detail oriented and able to effectively communicate findings verbally and in writing.