Quality Assurance Auditor – Everett, Washington
Join one of the fastest growing CRO in North America, with a unique focus on supporting drug
development from lead candidate selection to proof of concept is seeking to add a Quality Assurance Auditor to our growing team.
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.
Responsibilities:
- 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
Requirements:
- Bachelor 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
- 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
With over 25 years of industry experience, we provide preclinical and clinical solutions to an
international customer base of biopharmaceutical companies. Our full-service offering in this critical stage of drug development includes program management, preclinical safety testing, clinical pharmacology services, manufacturing and analytical services, medical writing, biostatistics, data management, and bioanalysis services tailored to specific research requirements.
