Job Description
Insight Global is looking for an investigator for one of our top pharmaceutical clients to support their site in Morris Plains, NJ. This role will author and oversee deviations, investigations, CAPAs, and related reports to ensure closure within the established timelines for the manufacturing department.
This role opens deviations, assesses their criticality within required timeframes, and evaluates any potential product impact in alignment with batch release activities. The specialist authors and owns investigations from initiation through closure, applying process knowledge and root cause analysis tools to identify true root causes of product and process deviations. They ensure all critical and major investigations are robust, accurate, complete, and fully defendable, and they design and execute experiments or test runs as needed to support investigation findings. Working cross‑functionally, the specialist collaborates with Manufacturing, Quality Control, Engineering, and other partners to analyze deviations, determine impact, and ensure production continues in a compliant manner with appropriate documentation.
In addition, the role is responsible for generating and documenting effective corrective and preventive actions (CAPAs) that address identified root causes and prevent recurrence. The specialist ensures CAPAs are implemented through appropriate GMP systems, such as manufacturing batch record revisions, training updates, or procedural changes, and monitors their progress through structured effectiveness checks. They also communicate with facilities and training teams to reinforce quality behaviors and support awareness initiatives, while contributing to SOP updates as needed to maintain compliance and drive continuous improvement.
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/.
Required Skills & Experience
2-5 years of experience within pharmaceutical environment
GMP, Aseptic, sterile experience
Strong documentation skills both written and verbal
Bachelor's Degree in scientific related field
Nice to Have Skills & Experience
Cell and gene therapy
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.