Job Title: Electronic Document and Data Control Specialist
Job Profile: Engineer II, QA
Reports To: Quality Systems Manager
Career Band: 5
Job Track: Associate
Position Location: Lenexa, KS
Number of Direct Reports: 0
Day/Shift (if applicable): NA
FLSA Status (Exempt/Non-Exempt): TBD
Relocation (if applicable): No
The Electronic Data Control (EDC) Specialist is a key member of the MBD Lenexa Quality Systems team responsible for educating site Managers on MasterControl system capabilities to drive efficiencies and compliance across the site. The EDC Specialist will work closely with entire Quality team to further develop MBD Quality systems processes and connect all MBD business segments, functional departments, and regional Quality organizations.
The position is also responsible for driving a quality culture consistent with Division and Corporate objectives. Success will be measured by the ability to leverage the tools and capabilities of the MasterControl software suite to effectively manage the control and flow of the processes of the quality system, including documents, training and forms. This is required not only at the Lenexa site, but between the quality groups at all of the Microbiology sites.
- Operate as the administrator for the MasterControl Quality Management Systems software suite, including, but not limited to the following:
- the design, maintenance, and control of the routing for all electronic forms.
- all reporting from the MasterControl system, including tracking and trending of system data.
- maintenance of all users accounts in the system.
- coordination of training modules for job codes and curriculum.
- collaboration, approval, and training of electronic documents.
- Partner with Quality Manager to provide ongoing MasterControl education across the site.
- Maintain and monitor processes for compliance with the Quality Systems Regulations and internal procedures.
- Review operating processes and controls to ensure quality efforts are practiced (how is this different from the bullet above?)
- Participate in general review and update of Standard Operating Procedures according to Food & Drug Administration Quality System Regulations, ISO 9001, and internal procedures.
- Ability to listen to and follow written and verbal instructions.
In addition, other duties may be assigned as the need arises.
- B.S. degree, preferably in a biomedical or quality field.
- Experience with Microsoft Office Suite programs.
- Possess a minimum of three years of experience in quality, product reliability, and/or product development in a quality, manufacturing environment.
- Possess knowledge of FDA, Medical Devices, and ISO regulations for device manufacturing.
- Possess prudent and practical decision-making abilities.
- Working knowledge of html and java script programming for use in creating and preparing process forms in the Master Control quality management system, preferred.
Non-Negotiable Hiring Criteria:
- Knowledge of proper grammar/English/spelling and journalism skills to create and/or edit documents from oral, written or transcribed draft information.
- Basic math skills.
- Possess excellent verbal and written communication skills.