Quality Assurance Auditor

BASIC SUMMARY:
The Quality Assurance (QA) Auditor performs audits of protocols, in-life critical phases; raw data and final reports of basic complexity and of routine study design conducted at the Testing Facility to assure accuracy and compliance with Good Laboratory Practice Regulations (GLP) and Standard Operating Procedures (SOP) and maintain written and signed records of auditing activities. The QA Auditor I applies discretion and independent judgment in providing recommended corrective actions to management and the study director. Additional responsibilities include: perform site Quality System audits (process/facility/equipment/validation) and review of corresponding regulatory documentation to ensure compliance; assist with qualification audits of subcontractors; may assist with sponsor/agency site audits; and participate in QA projects.

ESSENITAL DUTIES AND RESPONSIBILITIES:
• Review protocols for compliance with all pertinent government and international GLP regulations for studies conducted at the Test Facility that are basic and routine in study design.
• Perform raw data audits for studies to ensure accuracy and compliance with the GLPs, study protocol and Standard Operating Procedures.
• Audit in-life critical phases of ongoing studies for compliance with the GLPs, study protocol and Standard Operating Procedures.
• Review final reports to ensure accuracy and compliance with GLP regulations and the study protocol/amendments; ensure that the final report accurately describes the raw data and study methods.
• Determine and assure that study deviations are appropriately reported and documented.
• Prepare and sign the Quality Assurance Statement to be included with audited final report.
• Prepare and review Quality Assurance files prior to Sponsor site visits; ensure that QA audit files are archived.
• Perform audits of site Quality Systems (process inspections; facility inspections; equipment and record review; computer validation activities; training records) including audits of corresponding regulatory documentation to ensure compliance.
• Assist in training of Quality Assurance personnel.
• Assist in providing and documenting company-wide GLP training sessions.
• May provide support during government/agency inspections, as requested.
• May assist in scheduling and tracking Quality Assurance audits inspections and procedures, as requested.
• Participate in qualification audits of subcontractors, as requested.
• Participate in Quality Assurance projects, as requested.
• Perform all other related duties as assigned.

REQUIREMENTS


QUALIFICATIONS:
• Education: Bachelor’s degree (B.S. /B.A.) or equivalent, preferably in a life science or related discipline.
• Experience: Minimum of 1 to 2 years in a Quality Assurance role.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certifications/Licensure: N/A
• Other: Experience with Microsoft Office® applications and spreadsheet programs such as Access and Excel. Position requires the individual to be able to communicate clearly, effectively and professionally; attention to detail and strong writing skills are essential.

PHYSICAL DEMANDS:
• Must be able to observe laboratory procedures to ensure that compliance with protocol, SOP's and GLP's.
• While performing the duties of this job, the employee is regularly required to talk, hear and type at a computer.
• Specific vision abilities required by this job include regular close vision and the ability to adjust focus.
• Must be able to regularly read, understand, and verify scientific text and data.
• On average, will sit 6 hours a day but on occasion could remain seated the entire day. Conversely, there may be occasions where an auditor may have to be mobile throughout the work day.
• Must be able to conduct training sessions for all company personnel.