cGMP Deviation & CAPA Lead

AGW; Greenville (NC); On-site; USD 41,000 - 55,000; Full time

Benefits offered by this job

Medical

Vision

Sick Pay

Job summary

Aptask Global Workforce (AGW) in Greenville, NC seeks a Deviation Management Specialist for a 12+ month contract. You will identify deviations from SOPs, conduct root-cause investigations, and develop CAPAs to ensure cGMP compliance in a regulated environment.

This role requires meticulous documentation, regulatory liaison, and participation in audits. Strong writing, data analysis, and communication skills are essential, with proficiency in Microsoft Office.

Qualifications

• Experience in regulated industry and cGMP environment.
• Strong attention to detail and analytical/problem-solving abilities.
• Intermediate to advanced Microsoft Word, Excel, PowerPoint.

Responsibilities

• Identify and document deviations from SOPs, quality standards, or regulatory guidelines.
• Conduct thorough investigations to determine root cause of deviations.
• Collaborate with cross-functional teams to develop and implement CAPAs.
• Maintain accurate records of deviations, investigations, and CAPAs.
• Prepare and present deviation reports to management and regulators as required.
• Ensure documentation complies with GDP.
• Ensure deviations are managed in compliance with policies and regulatory requirements.
• Participate in internal and external audits and inspections.
• Analyze deviation trends and provide insights for continuous improvement.
• Participate in training to enhance deviation management and QA knowledge.

Skills

cGMP experience

Attention to detail

Technical writing

Analytical skills

CapA development

Microsoft Office (Word, Excel, PowerPt

Communication skills

Education

Associate or bachelor's degree in Life Sciences/Engineering/Quality

Tools

Electronic documentation systems

Job description

Aptask Global Workforce (AGW) in Greenville, NC seeks a Deviation Management Specialist for a 12+ month contract. You will identify deviations from SOPs, conduct root-cause investigations, and develop CAPAs to ensure cGMP compliance in a regulated environment.

This role requires meticulous documentation, regulatory liaison, and participation in audits. Strong writing, data analysis, and communication skills are essential, with proficiency in Microsoft Office.