QA GCP Auditor II

About the role

A Quality Assurance Auditor II is responsible for conducting various types of routine and for cause audits including, but not limited to: site audits, trial master file audits, vendor audits, internal process audits, validation and database audits and documenting these audits within EvestiaClinical’s Clinical Trial Management System or shared drive.

Responsibilities

• Conduct audits to ensure compliance with local and federal regulations, ICH GCP, Protocol and, where applicable, Evestia Clinical’s or Sponsor’s SOPs
• Auditors may assist in audit preparation prior to third party and regulatory audits
• Works under limited supervision, reporting to the Director of Quality Assurance and participates in project team audit follow up meetings to develop appropriate resolution plans or CAPAs
• Serves as a regulatory reference for Sponsors and Evestia Clinical staff
• Auditor II may host or participate in a qualification audit of Evestia Clinical and represent Evestia Clinical in a study Kick-off meeting
• Additional responsibilities include leading portions of New Employee training
• May assist Director of Quality Assurance in QA SOP development and other quality management activities such as participation or hosting of Quality by Design meetings
• Occasional travel may be required

Requirements

• BA, BS or MS preferably in bio-scientific, health care or life sciences
• GCP experience is essential
• At least 4 years' experience as a GCP auditor, an on-site clinical monitor, or in system validation
• Previous auditing training or experience preferred
• ACRP CCRA, SoCRA CCRP, RAC, SQA GLP or GCP certified preferred
• Superior clinical auditing and/or monitoring skills, excellent decision-making skills, and sound judgment
• Current and working knowledge of Federal Regulations, ICH /GCP and applicable SOPs
• Computer skills and ability to learn and become proficient with Evestia Clinical’s Clinical Trial Management System and Microsoft Office
• Willingness to assist with tasks not specifically outlined in this description

Qualifications

• BA, BS or MS preferably in bio-scientific, health care or life sciences
• At least 4 years' experience as a GCP auditor, an on-site clinical monitor, or in system validation
• Superior clinical auditing and/or monitoring skills, excellent decision-making skills, and sound judgment
• Current and working knowledge of Federal Regulations, ICH /GCP and applicable SOPs
• Computer skills and ability to learn and become proficient with Evestia Clinical’s Clinical Trial Management System and Microsoft Office

Skills

• ACRP CCRA, SoCRA CCRP, RAC, SQA GLP or GCP certified

Benefits

• Health Insurance: 99% employer-paid
• Dental & Vision Insurance: 100% employer-paid
• Short-Term & Long-Term Disability: 100% employer-paid
• Life Insurance Policy
• 401(k) Retirement Plan: 3% employer contribution
• Flexible and Hybrid Work Options
• Unlimited PTO for salaried staff
• 12 Corporate Holidays
• Employee Assistance Program (EAP)
• Wellness Program
• Learning & Development Stipend: Increases with tenure
• Charitable Match Program
• Wednesdays Catered Lunches (In-Office)

Pay

Commensurate with experience

Schedule

Full-time