System Configuration Specialist/Subadmin
Company Overview
11 Compliance Consulting specializes in electronic quality system support and implementation for Biotech, Medical Device, and Pharmaceutical companies.
Position Overview
11 Compliance Consulting is seeking a System Configuration Specialist to join our rapidly growing team. The System Configuration Specialist will be responsible for creating, maintaining, and improving the configurations for our customers.
Position Responsibilities
* Perform technical review of procedures.
* Conduct client system audits in various areas of configurations to identify potential areas of improvement and/or enhancements.
* Interface with customers as required for the successful deployment and maintenance of the system and associated modules.
* System configuration for documents and training modules regarding initial implementation, upgrades, and improvements for clients and the company’s system.
* Aid with client meta-data entry and importing documents into their system.
* Assist clients with tech support issues and follow up as needed, work with tech support to identify issue source and resolve.
* Set up new users in the company’s system to support the onboarding process.
* Provide support in the development of internal standard operating procedures, work instructions, and job aids.
* Other work as directed.
Skills Required
* Subadmin knowledge of MasterControl QMS.
* Proficient with standard MS Office programs.
* Knowledge of ISO 13485; ISO 9001:2015.
* Knowledge of applicable regulations (GMP, GCP, FDA regulations with a focus on 21 CFR part 11 and Annex 11).
* Strong communication skills with the ability to communicate cross-functionally with all organizational levels.
* A hands-on, self-directed, detail-oriented, and conscientious individual.
This position is for onsite location but may have opportunities for remote work based on experience.
Seniority Level: Entry level
Employment Type: Full-time
Industries: Pharmaceutical Manufacturing
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