Responsible for quality computer system administration, providing technical/end user support for quality computer system(s) The role requires assisting in quality computer system validation efforts that is executed in compliance with cGMPs, company policies and procedures, 21 CFR Part 11, EU Annex 11, ICH guidelines, and other applicable industry regulations.
• Provide technical support and system troubleshooting for end users.
• Provide daily support for end users on system navigation and business process questions.
• Administer user access, to include:
○ access group maintenance
○ training environment user access maintenance
• Develop and maintain a strong partnership with internal departments and quality users to achieve business and project goals.
• Assist with maintaining validation documentation deliverables such as URS, FRS, Configuration Specification (CS), and Requirements Traceability Matrix (RTM), and system procedures (SOPs) in accordance with cGMP, 21 CFR Part 11, EU Annex 11, and related regulatory requirements to ensure the system is maintained in a validated state.
• Monitor and support completion of projects to ensure project deadlines are met while communicating status accordingly.
• Assist with implementing quality system training programs, including development of training materials and training curriculum content in collaboration with the Training Department.
• Schedule and provide classroom training as applicable to each system.
Able to react to change productively and handle other essential tasks as assignedSkills:
• Bachelor degree (or Associate Degree and additional related work experience) in pharmaceutical science, biology, chemistry, or related science/ IT.
• Working knowledge of FDA and/or EMEA regulatory requirements/guidelines as they relate to all aspects of quality systems and compliance (i.e., 21CFR Part 11, Data Integrity, etc.) desired.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.