11 Compliance Consulting is a company which specializes in electronic quality system support and implementation for Biotech, Medical Device and Pharmaceutical companies.
Position
This position is onsite in Swansea, Massachusetts; this is not a remote position. We are currently looking to hire a Quality System Engineer with experience using an eQMS system who can assist clients with data entry and configuration management as needed.
Position Responsibilities
* Conduct technical reviews of procedures to ensure accuracy and effectiveness.
* Perform audits of client systems to identify opportunities for improvement or enhancement.
* Interface with customers to facilitate the successful deployment and maintenance of the system and associated modules.
* Configure eDMS and LMS systems for initial implementation, upgrades, and process optimization.
* Support clients with meta-data entry.
* Provide technical assistance to clients and follow up to ensure issue resolution.
* Collaborate with vendor technical support to diagnose and resolve system issues.
* Set up new users in the company’s system to support the onboarding process.
* Manage the setup of new users within the company’s system to streamline the onboarding process.
* Contribute to the development of internal Standard Operating Procedures (SOPs), Work Instructions, and Job Aids.
* Other work as directed.
Skills
* 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.
Seniority Level: Entry level
Employment Type: Full-time
Job Function: Information Technology
Industries: Pharmaceutical Manufacturing
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