The Quality Assurance Auditor coordinates auditing activities to ensure compliance with SOPs and GLP requirements. Performs a wide variety of activities pertaining to assuring compliance with applicable regulatory requirements by conducting audits and inspections, supporting training programs, data and documentation reviews.
Duties
Audits protocols, amendments, raw data, reports and supporting documentation for internal accuracy, consistency, and conformance with regulations and internal SOPs
Performs phase inspections of ongoing study activities
Performs facility audits to ensure departmental compliance with the regulations
Oversees and assists with audits to assure departmental consistency
Prepares, issues, and tracks reports of observations noted during audits and inspections
Applies a thorough understanding of compliance to a broad range of regulatory issues
Maintains computerized files to support audit activities
Assists in scheduling audits and assigning resources to projects
Coordinates auditing activities and implements auditing systems to ensure compliance with GLP requirements
Identifies, evaluates, and implements best practices
Evaluates interdepartmental processes for improvement opportunities and proposes solutions
Helps design and develop risk-managed regulatory processes
Oversees and designs training systems; acts as a lead trainer for new and junior staff
Drives project planning and implementation; acts as lead auditor on studies
Solicits and gains support of employees, clients and management through effective collaboration and negotiation; represents QA in workgroups
Evaluates interdepartmental processes for improvement opportunities and proposes solutions
Oversees and designs training systems; trains and qualifies trainers on internal processes and procedures
Communicates with clients regarding regulatory issues
Qualifications
Bachelor's degree (B. S.) in a scientific discipline, or equivalent combination of education and experience
Two to three years related technical experience and/or training. A minimum of two years auditing in a GLP-regulated environment. Lab auditing preferred
Professional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (American Society of Quality – Certified Quality Auditor) or other certification is recommended
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Staffing and Recruiting
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