A Full-time, Software Administrator job is available with our client, a biopharmaceutical company, in Boca Raton, FL!
As the Software Administrator you will support the maintenance and end users of various GMP systems by maintaining master data, providing training, supporting end users, and end users accounts, while ensuring compliance. This position is responsible for acting as a technical liaison between business needs of GMP software system users and the Data Integrity department. This position requires functional knowledge of a plasma donor center workflow, pharmaceutical manufacturing, regulations including GAMP and cGMP, and interacts with multiple technical and non-technical personnel.
DAY-TO-DAY RESPONSIBILITIES:
- Supports maintains software for BioCenters (NexLynk, NexSys PCS) and within the Boca Site GMP operations (PAS, MES, BMS)
- Supports end users in the BioCenters and Boca Site GMP operations by responding to tier 1 and tier 2 help desk tickets for all cGMP applications, including onsite troubleshooting of issues encountered within software
- Provide end user support and training for various IT systems
- Manage user accounts and security roles for IT systems.
- Supports software functional validation to cGMPs, including data integrity and maintains system compliance with GAMP5. This includes working with end users to define specification requirements and providing input for qualification protocols for the validation of said systems.
- Troubleshoots discrepancies and errors. Works with vendor technical support and remote consultants to resolve software issues.
- Provide data for analysis utilizing available data and reporting tools.
- Responds and resolves system user inquiries.
- Responds to both help desk tickets and direct communication with end users to resolve issues with cGMP applications within the BioCenter and Manufacturing user base.
- Develops, and maintains Software Standard Operating Procedures Analysis and Systems Development
- Partner with quality control, quality assurance, analytical and process development, IT, facilities and Boca site operations staff on a regular basis to understand software related requirements and business processes. Analyzes and identifies enhancements to the current system functionality to improve practices and achieve efficiency.
THE SKILLS YOU NEED TO GET THE ROLE:
Education Requirements:
- Bachelor’s degree in computer sciences, biological sciences, or related discipline or equivalent experience.
Experience Requirements:
- 1-3 years’ experience in information system and /or a laboratory /facilities setting related to information systems.
- Basic system administration of cGMP applications.
- Knowledge of industry regulations (such as GAMP, cGMP, cGLP, GDP, etc.) is required.
- Direct experience working in a laboratory a plus. Working knowledge of SQL or Power BI a plus.
After you've applied, connect directly to the recruiter at linkedin.com/in/manisha-kuril-22b310150
