• QC Analytical Investigator

    Insight Global (Boston, MA)


    Job Description

    Insight Global is looking for a QC Analytical Investigator to sit on-site at a brand new facility in the beautiful Seaport district of Boston supporting one of our top pharmaceutical clients. This is a first shift role, on-site Monday through Friday. This position will be supporting the growing technical services team in their risk assessment efforts. This role will be responsible for conducting RCA, assessing impacts, and developing CAPAs to ensure efficient and effective processes across the cell and gene therapy organization. A strong candidate for this role will have a strong background in QC Analytical risk assessments, in GMP environment, leading, writing and reviewing deviations and investigations. Th This person will need to be comfortable managing several projects simultaneously with various stakeholders, maintaining a project management mind-set. Additionally, they should be comfortable working independently and confidently managing decisions on their own. This is an amazing opportunity for a mid-level professional to get their foot in the door at a fast-paced and high growth company and take the next step in their career!

     

    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) .

     

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    Skills and Requirements

    • 3+ years of QC Analytical risk assessment management experience in a GMP environment

    • Project management experience, comfortable managing multiple stakeholder relationships

    • Strong technical writer with previous experience authoring, reviewing and editing risk assessment, CAPA and deviation documents

    • Effective communicator with ability to influence a group of people

    • Previous experience with an eQMS system, ideally Veeva

     

    Bachelor's Degree