Senior Quality Systems Specialist

Senior Quality Systems SpecialistInsight Global is seeking a Senior Quality Systems Specialist to support critical quality and compliance initiatives within a regulated pharmaceutical/biotechnology environment. This role will play a key part in quality remediation efforts resulting from audit observations, with a strong focus on quality systems review, risk management, technical documentation, and continuous improvement activities.The Senior Quality Systems Specialist will conduct systematic assessments of microbiology-related programs and quality processes to identify gaps, ensure compliance with regulatory requirements, and recommend best practices. This position takes a strategic and theoretical approach to microbiology quality oversight rather than performing bench-top laboratory testing.Key responsibilities include authoring and reviewing risk assessments, supporting quality system remediation projects, conducting technical investigations related to out-of-specification (OOS) events, and developing corrective and preventive actions (CAPAs). The specialist will be responsible for technical writing, preparing quality documentation, analyzing quality trends, and ensuring that quality practices align with industry standards and regulatory expectations.