GxP Quality Specialist: eQMS, CAPA & Audits (Remote)

ProPharma Group; United States; Hybrid; USD 70,000 - 110,000; Full time

Benefits offered by this job

Hybrid work model

Remote work option

Job summary

ProPharma Group is seeking a Quality Assurance professional to ensure GxP compliance across the full service lifecycle. You will support eQMS activities, track CAPAs, and coordinate responses to audits and inspections.

The role requires strong organizational skills, attention to detail, and excellent communication for collaboration with clients and internal teams. A hybrid work model and remote options are available.

Qualifications

• Fluent in English speaking and writing.
• Knowledge and experience with GXP Quality Management Systems.
• Proficient in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).
• Excellent organization, prioritization, and communication skills.

Responsibilities

• Maintain awareness of and ensure compliance with GxP guidelines and regulations for services provided.
• Support eQMS activities (Change Control, Deviations, QEs, CAPAs, Effectiveness Checks).
• Develop, recommend, and monitor Deviations, QEs and CAPAs; communicate root causes to stakeholders.
• Participate in GxP change management activities including risk analysis and action plan tracking.
• Support client audits and regulatory inspections, coordinating agendas and document provision.
• Coordinate and manage audit CAPA responses with SMEs; track records in eQMS.

Skills

Fluent English

GxP Quality Management

Quality Assurance

Regulatory Compliance

Audits

Tools

Microsoft Office

Job description

ProPharma Group is seeking a Quality Assurance professional to ensure GxP compliance across the full service lifecycle. You will support eQMS activities, track CAPAs, and coordinate responses to audits and inspections.

The role requires strong organizational skills, attention to detail, and excellent communication for collaboration with clients and internal teams. A hybrid work model and remote options are available.