Job Description Insight Global is hiring a Sr. Quality Specialist to join our large pharmaceutical client in Boston, MA. As part of the GMP Operational group, you will provide quality oversight and support to cell and gene therapy operations, including manufacturing, analytical labs, materials management, and facility/engineering. You will lead QA efforts for new Drug Product facility programs, including assembly, packaging, and labeling operations. Responsibilities include batch disposition activities, reviewing batch data, and approving COAs and product releases. You will provide production floor support, resolve significant quality issues, and make product disposition decisions. Additionally, you will develop technical training programs, support change controls, GMP investigations, and CAPAs, and offer technical advice for fill-finish programs. You will participate in compliance walkthroughs, inspection readiness, and process improvement initiatives. Acting as a trusted advisor, you will provide compliance guidance and facilitate the resolution of quality issues, including product complaints and recalls. Pay Range: $55/hr - $65/hr (pay rate determined by multiple factors including level of degree, years of experience, relevant experience, etc.) 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 .     To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ . Skills and Requirements -Proficient in ATMP drug product development and manufacturing, with extensive knowledge of cell and gene therapy cGMPs, CMC regulatory considerations, and aseptic processing. -Successfully led event investigations, Root Cause Analysis, and CAPA initiatives. -Experience providing QA support and oversight for GMP manufacturing operations, including batch release. -Bachelors degree in a scientific or allied health field with 3-5 years of relevant experience, or a Masters degree with 2-3 years of relevant experience. null 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 employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to 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 oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.