Principal Quality Associate, QA, General Computer Systems

Jobtailor; Clayton (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Jobtailor is seeking a Sr. Quality Associate to lead risk assessments and remediation for GxP computer systems in a regulated environment. You will oversee user access, security roles, and electronic records controls, and review validation documentation to ensure systems stay in control.

The role requires a STEM degree and several years of relevant experience, with strong decision-making and communication skills essential for success.

Qualifications

• Demonstrated ability to independently make sound quality decisions.
• Excellent communication skills (written and verbal).

Responsibilities

• Lead and support data integrity risk assessments, gap assessments, and remediation activities for GxP computer systems.
• Provide Quality oversight for user access management, role-based security, audit trail review, and electronic records/electronic signatures controls.
• Review and approve validation lifecycle documentation for computerized systems.
• Partner with system owners and business stakeholders to ensure validated systems remain in a state of control.

Education

BS/BA degree in STEM

Job description

Responsibilities

• Lead and support data integrity risk assessments, gap assessments, and remediation activities for GxP computer systems
• Provide Quality oversight for user access management, role-based security, audit trail review, and electronic records/electronic signatures controls
• Review and approve validation lifecycle documentation for computerized systems
• Partner with system owners and business stakeholders to ensure validated systems remain in a state of control

Requirements

• BS/BA degree preferably in a STEM discipline with minimum of 5 years relevant experience for Sr. Quality Associate I or a minimum of 6 years for Sr. Quality Associate II or a minimum of 8 years for Principal Quality Associate
• Demonstrated ability to independently make sound quality decisions
• Excellent communication skills (written and verbal)