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Quality Systems Software Architect I #656 (temp to hire)
Durham, NC
Job Description
*Please Note: This position is fully remote*
JOB SUMMARY:
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.
JOB RESPONSIBILITIES:
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
JOB SUMMARY:
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.
JOB RESPONSIBILITIES:
- 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:
- on-boarding
- off-boarding
- 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 assigned.
- Bachelor degree (or Associate Degree and additional related work experience) in pharmaceutical science, biology, chemistry, or related science/ IT.
- 1 - 2 years of combined experience in quality computer system support and administration in the pharmaceutical/biopharmaceutical industry preferred. Some experience with JavaScript or Python desired.
- 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.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
Job Summary
Company
Start Date
Immediately
Employment Term and Type
Regular, Full Time
Hours per Week
40
Salary and Benefits
Competitive
Required Education
Bachelor's Degree
Required Experience
1 year
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