Job Description One of our large pharmaceutical clients is looking to hrie a QC Investigator to join the QC team in Malvern PA. This individual is responsible for authoring nonconformance investigations and corrective and preventative action records, document management, investigation and assay trending, root cause problem solving, and human performance factors analysis. This position requires analytical thinking, organizational leadership, and technical writing skills. This position will drive improvements within a global organizational framework. Responsibilities: -Performs and documents all QC investigations (non-conformance, deviations, invalid assays) -Authors and executes corrective and preventative action record -Tracks deviations and events and provides reports to management on trending, and status as requested. Recommends corrective actions for any trends identified -Manages change through chance control process -May performs Gap Assessments for local QC documents against new standards and other quality documents -Executes CAPAs when required for the Quality Control organization -Works with compliance to provide QC input for the APR -Reports data from QC as required for the site management review -Maintains individual training completion in a compliant state -May be asked to participate in audits -Support Health Authority inspections -Provide input to functional laboratory meetings -Make decisions as a QC representative at cross-functional meetings -Provide leadership and insight as a member of global project teams -Provide QC input as a member of Quality focused projects 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 -Minimum of a bachelors degree is required -Minimum of 2-4 years of relevant experience performing quality investigations or technical writing -Skilled in basic and advanced analytical methodologies within the functional laboratory is required -Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems is required -Ability to independently perform project management functions is preferred -Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols is required -Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint) is required -Trackwise or Comet 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.