QA Auditor III: Lead GxP & Client Audits

Regulatory Jobs; Richmond (VA); Presencial; USD 80.000 - 120.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific in Richmond, VA is seeking a Quality Assurance Auditor III to join our BIOA Laboratory onsite. You will lead diverse client, internal, and GxP audits, ensure compliance with global regulatory standards, and prepare audit reports for management and clients.

Requires a Bachelor's degree or equivalent and 5+ years QA experience, strong communication, and root-cause analysis; ability to travel. Onsite role in Richmond; must be authorized to work in the US.

Formación

• Detailed knowledge of GxP and regional guidelines.
• Experience leading client, internal or GxP audits.
• Excellent oral and written communication skills.
• Strong risk assessment and root cause analysis abilities.
• Ability to multi-task and prioritize demands.
• Valid driver's license and ability to travel.

Responsabilidades

• Lead client, internal or GxP audits and inspections as requested.
• Lead site, facility, vendor and sub-contractor audits.
• Provide GxP consultation and support to project teams.
• Lead process audits and participate as co-auditor in complex audits.
• Perform other QA audits or activities (e.g., database and study report audits).
• Serve as resource to operational departments on audit matters.
• Prepare and present audit findings at meetings.
• Mentor and guide junior auditors.

Conocimientos

GxP knowledge

Audit leadership

Communication skills

Problem solving

Root cause analysis

Negotiation

Multi-tasking

Driver's license

Educación

Bachelor's degree or equivalent

Relevant formal qualification

Descripción del empleo

Thermo Fisher Scientific in Richmond, VA is seeking a Quality Assurance Auditor III to join our BIOA Laboratory onsite. You will lead diverse client, internal, and GxP audits, ensure compliance with global regulatory standards, and prepare audit reports for management and clients.

Requires a Bachelor's degree or equivalent and 5+ years QA experience, strong communication, and root-cause analysis; ability to travel. Onsite role in Richmond; must be authorized to work in the US.