Responsibilities:
* Auditing
o Conducts audits based on priorities that may include:
1) critical phase
2) reports
3) raw data
4) facilities
5) computer software to ensure compliance with governmental regulations
o Assesses the ability to reconstruct scientific studies based on the protocol, raw data, and reports, using an understanding of scientific principles and/ or mathematical calculations and formulae.
o Assure the report accurately describes the methods and procedures and that the reported results accurately reflect the study's raw data.
o Communicates audit findings appropriately using effective oral and written communication skills.
* Provides support for the Quality Assurance Unit as needed.
o Exercises discretion for resolution of issues/problems identified relative to GLP standards; confers with on-site supervisor on unusual matters.
* Reviews and applies applicable Standard Operating Procedures (SOPs).
* May participate in alignment teams to provide input and ensure consistency in QA processes across sites.
* Collaborates with auditors across GLP sites as needed.
* Fosters collaborative relationships with stakeholders to ensure an effective partnership.
* Ability to handle confidential material appropriately.
* Ability to use computer software and applicable databases to access, review, collect and synthesize information.
* Strong attention to detail -- willingness to dive in and research issues and problems as they arise.
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/ .
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.