Job Description One of our large pharmaceutical clients in Malvern, PA is seeking a Compliance Specialist to join their growing team supporting the Biologics (large molecule) organization within R&D. This person will be responsible for supporting audits, driving nonconformance investigations, risk analysis, corrective and preventative action records, document management, assay trending, root cause analysis, and human performance factors analysis. This position requires analytical thinking, organizational leadership, and strong written and verbal communication skills. Other responsibilities include: -Independently run investigations (non-conformance, deviations, invalid assays) -Identify gaps in processes or systems based on current and future regulatory requirements and communicate necessary changes to leadership and appropriate stakeholders -Risk assessments -Author and execute corrective and preventative action record and execute CAPAs when required -Track deviations and provide reports to management on trending, and status as requested. Recommend corrective actions for any trends identified. -Manage change through change control process and support internal and external audits -Keep track of regulatory requirements and changes and perform Gap Assessments as needed -Provide input and make decisions at cross-functional meetings and provide leadership and insight as a member of global project teams -Process improvement We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, 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 Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) . 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 -Minimum of a Bachelor's Degree in a scientific discipline -2+ years of related investigation and/or compliance experience in a GMP laboratory -Experience performing change controls, assessing risks, executing plans in accordance with approved plan -Knowledge and understanding of current Good Manufacturing Practices (cGMP) and ability to identify gaps in processes or systems based on current and future regulatory requirements -Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols -Strong communication skills and ability to work with multiple internal and external stakeholders in a matrixed environment at a global scale -Ability to work onsite in Malvern 3-5 days/week -Experience conducting end to end investigations and defining corrective action plans -Comet or TrackWise experience -Project management 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.