QA Auditor

Summary:

The QA Auditor reports to the QA Manager and is responsible for carrying out systematic and independent examination (i.e., audit) of multiple clinical trial-related activities and documents, to determine whether the activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, standard operating procedures (SOPs) and Good Clinical Practices. They are responsible for reporting any findings to the Internal Study Team and department management (e.g., Team Manager, Study Manager, Director, etc.) and for building and maintaining effective working relationships throughout the organization.

Duties:

• Audits phases of laboratory and clinical studies, reports, and performs related duties (e.g., issues findings and QA statements) to ensure regulatory compliance.
• Audits all disciplines (examples of disciplines include Screening, Recruiting, Clinical Operations, Laboratory, Data Services).
• Performs in-life audits, process audits, vendor qualifications, equipment and software validation audits.
• Writes and issues inspection reports. Works with internal clients to ensure that inspection findings are clearly communicated and understood. Evaluates inspection finding responses to ensure they are written to address the findings appropriately.
• Ensures through phase and data inspections that the SOPs, which are involved in the conduct of a study, are current and practiced.
• Identifies and communicates opportunities for process improvement based on audit and inspection observations. Participates in and guides process improvement activities in both small intradepartmental groups as well as complex and possible multidepartment interactions.
• Maintains necessary documentation of QA records and study files.
• Notifies management of observed quality and compliance trends in the areas inspected. 
• Recommends modifications in procedures to fit special needs or problems and involves manager when assistance in process improvement/resolution is necessary.
• Interprets GCP, GLP, and GCLP and associated regulatory documents to facilitate auditing and process improvement recommendations.
• Prepares for RQAP-GCP and/or RQAP-GLP certification.
• Carries out appropriate self-development efforts as directed.

Qualifications: 

• Bachelor degree or higher, in Chemistry, Biochemistry, Biology, or equivalent field, or equivalent combination of education and experience, in the pharmaceutical industry
• Two to three years related technical experience and/or training. A minimum of two years auditing.
• 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
• QA GLP bioanalytical auditing experience is required