QA Auditor II — GxP & Regulatory Compliance Lead

Actalent; Richmond (VA); On-site; USD 52,000 - 61,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) retirement plan

Life Insurance

Disability insurance

HSA

PTO

Job summary

Actalent is seeking a QA Auditor II to elevate clinical auditing processes, ensuring regulatory compliance and quality standards. You will be a knowledgeable resource on audit/QA topics, auditing diverse processes including database audits and clinical study report audits.

The role involves leading audits, providing GxP consultation, and partnering with project teams to maintain high-quality standards in a fully onsite environment in Richmond, VA.

Qualifications

• Bachelor's degree or equivalent in a related field.
• 2+ years QA experience.
• Thorough knowledge of GxP and regional regulations.
• Demonstrated proficiency in leading audit projects.

Responsibilities

• Conduct and/or lead a variety of client, internal, or GxP audits and regulatory inspections.
• Perform directed site audits, facility, vendor, and/or sub-contractor audits.
• Provide GxP consultation and support to project teams and external clients.
• Lead process audits and participate as co-auditor in complex system audits.
• Perform other QA audits or activities, including database audits and clinical study report audits.
• Serve as a knowledgeable resource to operational departments on audit/QA topics.
• Prepare and present audit findings at meetings.

Skills

QA experience

GxP knowledge

Lead audits

Communication

Risk assessment

Root cause analysis

Vendor audits

Education

Bachelor's degree or equivalent

Job description

Actalent is seeking a QA Auditor II to elevate clinical auditing processes, ensuring regulatory compliance and quality standards. You will be a knowledgeable resource on audit/QA topics, auditing diverse processes including database audits and clinical study report audits.

The role involves leading audits, providing GxP consultation, and partnering with project teams to maintain high-quality standards in a fully onsite environment in Richmond, VA.