Quality Assurance Auditor 1Work with Purpose

We are seeking a Quality Assurance Auditor I, for our Quality Assurance Department located in Cleveland, Ohio. 

The position is responsible for performing audits of basic records and reports and inspections of routine processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures.

ESSENITAL DUTIES AND RESPONSIBILITIES:

• Review protocols for compliance with all pertinent government and international GMP and 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 GMPs and GLPs, study protocol and Standard Operating Procedures.
• Audit in-life critical phases of ongoing studies for compliance with GMPs and GLPs, study protocol and Standard Operating Procedures.
• Review final reports to ensure accuracy and compliance with GMP and 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 GMP and 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.

Qualifications

The following are minimum requirements related to the Quality Assurance Auditor I position.

• Bachelor’s degree (B.A./B.S.) required.
• 1 -2 years of experience preferred in science related field. 
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. 

 

The pay range for this position is $45k-$50k. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.