Job Description Insight Global is seeking a Quality Assurance Specialist to support one of our pharmaceutical clients. The QA Specialist will be responsible for the quality review and approval of change controls, investigations and CAPAs. Takes the quality lead role in reviewing commissioning / qualification / validation activities performed. Manages review of multiple commissioning, qualification, validation documents. QA oversight of shutdown related activities. Prepare and/or review Investigations and CAPAs related to equipment/instrument, facility, cleaning, QC, and process non-conformances. Interacts with internal and external cGMP audits. Reviewing SOPs related to quality systems. Overall QA review of SOPs related to Production, Engineering, Facilities / Maintenance, Validation, Supply Chain, and QC. 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 5+ years experience of GMP Quality Assurance in the Pharmaceutical industry Experience with executing and / or reviewing IQ/OQ/PQ validation documentation and protocols Experience with change controls, investigations, complaints, deviations, CAPAs, Root Cause Analysis Bachelors Degree in Life Sciences, Engineering or related field Experience with TrackWise, Veeva, LIMS, or similar quality systems 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.