Job Description Insight 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. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.

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https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements Bachelor's degree in Microbiology, Biology, Chemistry, Pharmaceutical Sciences, or related scientific discipline. 5+ years of experience in Quality Assurance, Quality Systems, Microbiology, or a related GMP-regulated environment. Strong experience with CAPAs, deviations, investigations, risk assessments, and audit remediation. Proven technical writing skills, including authoring investigations, risk assessments, and quality documentation. Working knowledge of FDA, EMA, ICH, and GMP regulations. Ability to analyze complex quality issues and develop practical, compliant solutions. Excellent communication, organizational, and stakeholder management skills.