Senior QA Auditor

About The Role

The Senior QA Auditor is responsible for carrying out systematic and independent examination (i.e., audit) of multiple study related activities and documents, to determine whether the evaluated study related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, standard operating procedures (SOPs), GLP (21 CFR Part 58 and Part 11) and the applicable regulatory requirements.

The Senior QA Auditor is responsible for reporting any findings to the Study Director or Responsible Person and Testing Facility Management. The Senior QA Auditor is responsible for building and maintaining effective working relationships throughout the organization and is responsible for mentoring/coaching lower-level staff.

The Senior QA Auditor is responsible for carrying out systematic and independent examination (i.e., audit) of multiple study related activities and documents, to determine whether the evaluated study related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, standard operating procedures (SOPs), GLP (21 CFR Part 58 and Part 11) and the applicable regulatory requirements.

The Senior QA Auditor is responsible for reporting any findings to the Study Director or Responsible Person and Testing Facility Management. The Senior QA Auditor is responsible for building and maintaining effective working relationships throughout the organization and is responsible for mentoring/coaching lower-level staff.

• Audits phases of nonclinical and laboratory studies, reports, and performs related duties (e.g., issues audits and QA statements) to ensure regulatory compliance.
• Audits all disciplines (examples of disciplines include Method Validations, Non
  - Clinical GLP Studies).
• Performs in-life audits, process audits, vendor qualifications, equipment and software validation audits.
• Performs facility audits to ensure that the facility is in compliance with regulations.
• Acts as lead auditor on studies and projects.
• Maintains computerized files to support audit activities.
• Supports project planning and implementation.
• Provides risk-based compliance opinions and guidance.
• 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 improvements based on audit and inspection observations. Participates in and guides process improvement activities in both small intradepartmental groups as well as complex and possible multi-departmental interactions.
• Maintains necessary documentation of QA records and study files.
• Notifies management of observed quality and compliance trends in the areas inspected.
• Autonomously performs SOP QA review, client hosting, regulatory agency hosting and external test site/clinical site/bioanalytical laboratory qualifications.
• Under supervision of a mentor/coach, performs the following tasks: interpretation of FDA, regulations; project management; regulatory guidance review; quality issue investigations; and QA data collection, trending and analysis.
• Recommends modifications in procedures to fit special needs or problems and involves manager when assistance in process improvement/resolution is necessary.
• Interprets and can train on GLP and associated regulatory documents to facilitate auditing and process improvement recommendations.
• Carries out appropriate self-development…