Quality Systems Associate Specialist
Core
Provide quality assurance support for pharmaceutical, medical device, and biologics manufacturing processes to ensure compliance with corporate and governmental regulations.
Role type
Associate Specialist in Quality Systems
Builds
Quality system documentation, specifications, and processes for product and system compliance
Domain
Life Sciences (Pharmaceuticals, Medical Devices, Biologics)
Required skills
Quality assurance, Regulatory compliance, Process sciences, Manufacturing operations, Change request management, Audit support, Documentation creation, CAPA implementation
Preferred skills
Chemistry/Pharmacy/Biology/Microbiology/Engineering degree, 3+ years QA experience, GMP compliance knowledge, Product/process/equipment familiarity, Cross-functional team collaboration
Technologies
GMP, CAPA, Validation, Document Center, Labeling systems
Responsibilities
Assist with integration of quality regulations for drug, biologics, and device products; Plan, prepare, review, and approve quality documentation; Create quality system documentation and specifications; Assist with audits of documentation, facilities, and equipment; Assess compliance to identify gaps and implement improvements; Participate in training and education programs.
Seniority
Mid-level, hands-on IC
