• QC Investigator

    Insight Global (Malvern, PA)


    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 [email protected].