Job Description
The Investigator will lead cross-functional investigations teams to identify true root cause of investigations, conduct risk assessments, and assess the impact of nonconformances. This individual will perform investigation and identify resolution for deviations and atypical events. They will recommend and coordinate implementation for corrective/preventative measures to improve compliance and ensure consistent quality standards are maintained.
Key Responsibilities:
Conduct root cause analysis investigations and author nonconformance reports.
Identify and implement process improvements related to safety, environmental, quality, compliance, efficiency, yield, and cost.
Recognize and act on potential compliance issues and opportunities for process changes/improvement.
Assure regulatory compliance and technical feasibility of proposed changes.
Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).
Coordinate data collection and trend analysis as requested by QA and Regulatory Affairs.
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
5 years of investigations experience
Understanding of GMP GDP GLP requirements
Bachelor's Degree
Great written communication skills
Nice to Have Skills & Experience
CART experience
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.