Job Description
Nature and Scope
The QA GxP Computer System Intern will ensure that American Regent's (ARI) GxP computer systems are implemented within GxP requirements. This position will support the Ohio GxP Team with system validation and administration activities. The specialist will work closely with all GxP team members within the department as well as other relevant ARI associates to complete tasks.
Essential Duties and Responsibilities
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
Assist in the collaboration with necessary business partners to develop CSV documentation required by ARI policy based on project assignments.
Assist with the review of the department SOPs and validation documentation for GxP systems.
Gather GxP system requirements from users as needed.
Draft and review software testing documentation.
Support system administration activities (user access; audit trail review).
SmartSheet workflow development, testing, and qualification.
DocuSign Template development and testing.
Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
1+ years of college level courses pursuing a degree in Information Systems, Computer Science, or related field.
Understanding of software design, implementation, and testing strategies.
Knowledge of Windows networks and servers.
Familiarity with software development life cycle.
Knowledge of manufacturing (GMP) processes, a plus.
General computer skills such as Windows and Microsoft Office required.
Other Enterprise software applications (SmartSheet, Veeva Vault, DocuSign), a plus
Strong written and verbal communication skills. Ability to work collaboratively a cross-functionally to achieve objectives.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
American Regent Inc. endeavors to make accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email .
We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
