Sr. Quality Specialist

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

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

Job Description

Position: Senior Quality Specialist

The Senior Quality Specialist will independently conduct and write complex formal investigation reports with input from area SMEs.

They will review drafted investigations, providing constructive feedback and acting as a coach to investigators when necessary.

The role involves performing impact risk assessments, assisting in root cause analysis, and planning appropriate corrective and preventive actions.

The incumbent will track and trend corrective and preventive actions to ensure timely closure.

This position also requires reviewing sensitive, confidential information and developing recommendations for the plant quality assurance department.

Position Responsibilities

• Conduct thorough investigations and write detailed reports.
• Review and evaluate investigation reports, providing feedback and coaching.
• Perform impact risk assessments and assist in root cause analysis.
• Plan and implement corrective and preventive actions, tracking their progress.
• Review sensitive information and develop recommendations for quality improvement.

Qualifications

Education and Experience:

• Bachelor’s degree in a science field preferred.
• 3-5 years of experience in an FDA-regulated pharmaceutical environment.

Additional Requirements:

• Experience in sterile manufacturing and understanding of sterilization processes.
• Knowledge of environmental monitoring and aseptic manufacturing.
• Understanding of process validation requirements.
• ASQ certification is an asset.
• Knowledge of FDA regulations and quality tools such as root cause analysis, DMAIC, fishbone analysis.
• Investigation writing experience, especially related to product impact.
• Strong communication, facilitation, and technical writing skills.
• Proficiency with Word, Excel, PowerPoint; TrackWise experience is a plus.

Organizational Relationships

Ability to interface effectively with personnel at all levels, including plant staff and senior management.