Sr. Quality Specialist

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.