Senior Quality Assurance Specialist
Core
Provide leadership-level quality oversight for drug product manufacturing operations, including formulation, fill/finish, assembly, packaging, and labeling.
Role type
Senior Quality Assurance Specialist (Manufacturing)
Builds
Drug product manufacturing operations (formulation, fill/finish, assembly, packaging, labeling)
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
Quality oversight, problem resolution, trend identification, system improvement, regulatory compliance, audit support, action plan implementation, change management, cross-departmental communication
Preferred skills
None stated
Technologies
None stated
Responsibilities
Provide operational support for formulation, fill/finish, assembly, packaging, and labeling activities; Act as an interface with Manufacturing Project Managers for quality-related issues; Resolve problems and identify trends to determine system improvements; Ensure compliance with internal procedures and regulatory expectations; Support audit and inspection readiness; Prepare and complete action plans to implement productivity and quality standards; Implement changes within GMP manufacturing guidelines; Oversee multiple projects as needed
Seniority
Senior, hands-on IC
