GxP QA Auditor II - Compliance & Audit Lead

Planet Pharma; Richmond (VA); On-site; USD 48,000 - 60,000; Full time

Job summary

Planet Pharma is seeking a QA Auditor to conduct and lead a variety of client and internal audits, including GxP inspections, ensuring compliance with regional guidelines. The role includes providing QA consultation to project teams and external clients, and serving as a resource to operations on audit matters.

The candidate should have a Bachelor's degree and 2+ years of QA experience, with strong communication, root cause analysis, and multi-tasking abilities. Some travel may be required.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• 2+ years QA experience in a similar role.

Responsibilities

• Lead client, internal or GxP audits and regulatory inspections as requested by senior management.
• Perform directed site, 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.
• Conduct other QA audits or activities (e.g., database audits, clinical study report audits, sample results tables, process improvement).
• Serve as a knowledgeable resource to operational departments on audit or QA subject matter.
• Prepare and present audit findings and related information at departmental, internal operations or client meetings.

Skills

GxP knowledge

Audit leadership

Regulatory compliance

Communication

Root cause analysis

Multi-tasking

Travel readiness

Driving license

Education

Bachelor's degree

Job description

Planet Pharma is seeking a QA Auditor to conduct and lead a variety of client and internal audits, including GxP inspections, ensuring compliance with regional guidelines. The role includes providing QA consultation to project teams and external clients, and serving as a resource to operations on audit matters.

The candidate should have a Bachelor's degree and 2+ years of QA experience, with strong communication, root cause analysis, and multi-tasking abilities. Some travel may be required.