Senior Quality Investigator & CAPA Leader

Integrated Resources Inc.; Rocky Mount (NC); On-site; USD 75,000 - 100,000; Full time

Job summary

A growing organization seeks a Senior Quality Specialist to lead complex investigations in an FDA-regulated environment. The role involves critical analysis, report writing, and quality assurance recommendations, targeting candidates with a science background and 3-5 years of relevant experience. Strong communication and technical writing skills are essential for interfacing with various departments.

Qualifications

• 3-5 years of experience in FDA-regulated pharmaceutical environment.
• Experience in sterile manufacturing and understanding of sterilization processes.
• Knowledge of FDA regulations and quality tools.

Responsibilities

• Conduct thorough investigations and write detailed reports.
• Perform impact risk assessments and assist in root cause analysis.
• Plan and implement corrective and preventive actions, tracking their progress.

Skills

Communication

Technical Writing

Facilitation

Education

Bachelor’s degree in a science field

Tools

TrackWise

Word

Excel

PowerPoint

Job description

A growing organization seeks a Senior Quality Specialist to lead complex investigations in an FDA-regulated environment. The role involves critical analysis, report writing, and quality assurance recommendations, targeting candidates with a science background and 3-5 years of relevant experience. Strong communication and technical writing skills are essential for interfacing with various departments.