Senior Quality Assurance Specialist

3 weeks ago


Webster Groves, Missouri, United States Mallinckrodt Pharmaceuticals Full time

About the Role:
The Senior Quality Assurance Specialist will serve as a key member of the Quality Systems organization at Mallinckrodt Pharmaceuticals, managing the development and establishment of quality programs, policies, processes, procedures, and controls. This role is responsible for ensuring that performance and quality of cGXP documentation conform to established standards and requirements. The scope includes management of Sector Audit and Supplier programs, Webster Groves Sector functions, and manufacturing sites.

Key Responsibilities:
- Manage self-inspection program
- Manage supplier quality program
- Provide backup technical support to TrackWise System administrator
- Conduct user training and support TrackWise system testing and upgrades
- Develop, establish, and maintain quality assurance programs, policies, process, procedures, and controls
- Identify, develop, and execute quality plans and project timelines to meet group, site, and company goals
- Participate in compliance audits and respond to audit observations
- Support FDA and other regulatory agencies investigations, inspections, and inquiries
Requirements:
- BS/BS in related field
- 10-15 years experience in pharmaceutical manufacturing and/or Quality with extensive FDA and global regulatory experience

Estimated Salary: $120,000 - $150,000 per year

Why Choose Us:
Mallinckrodt Pharmaceuticals is an equal employment opportunity employer, committed to diversity and inclusion. Our dynamic work environment provides unique experiences for employees to grow and develop. We offer competitive salaries, benefits, and opportunities for career advancement.



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