Job Description The Experienced Analyst Quality Control position for investigators supports the overall QC organization and 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 execute corrective and preventative action records  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 change control process  May perform 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 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 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 bachelors degree is required  Minimum of 3 years of experience conductting invetsigations within a QC lab or relevant space  Strong experience within tehcnical writing of complex investigations  Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols is required  Proficiency in using Microsoft office applications (outlook, excel, word, and PowerPoint) is required Experience with Flow Cyromtery and ELISA  Experience presenting investigation findings to auditors or regulatory agencies, including preparation of supporting documentation and responses to follow-up questions. 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.