Job Description
One of our large pharmaceutical clients in Spring House, PA is seeking an Investigator to join their growing team supporting the Cell Therapy Development organization within R&D. This person will be responsible for driving nonconformance investigations end-to-end, including root cause analysis, risk analysis, creating and owning corrective action plans, and updating procedures accordingly. This position requires analytical thinking, organizational leadership, and strong written and verbal communication skills.
Primary responsibilities include:
-Independently run investigations (non-conformance, deviations, invalid assays)
-Author and execute corrective and preventative action record and execute CAPAs
-Track deviations and provide reports to management on trending as it relates to assigned investigations
Additional responsibilities may include:
-Identify gaps in processes or systems based on current and future regulatory requirements and communicate necessary changes to leadership and appropriate stakeholders
-Risk assessments
-Manage change through change control process and support internal and external audits
-Keep track of regulatory requirements and changes and perform Gap Assessments as needed
-Process 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
-Minimum of a Bachelor's Degree in a scientific discipline
-5+ years of related investigation experience in a GMP laboratory
-Experience conducting end to end investigations and defining corrective action plans
-Knowledge and understanding of current Good Manufacturing Practices (cGMP)
-Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols
-Strong communication skills and ability to work with multiple internal and external stakeholders in a matrixed environment at a global scale
-Ability to work onsite in Spring House 3 days/week
Nice to Have Skills & Experience
-Comet or TrackWise experience
-Project management experience
Benefit packages for this role will start on the 31st 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.