Job Overview:
ComplianceQuest (CQ) is seeking a Senior Electronic Batch Record (EBR) Solution Consultant. The Solution Consultant plays a critical role in the success of the Implementation Services team. The Sr. EBR Solution Consultant is to provide product recommendations and configurations, ensuring proactive communication to clients and internal staff, and managing enhancement requirements and escalations and capability to understand simple to complex business requirements and design an EBR solution to meets those needs. The Sr. EBR Solution Consultant drives projects to completion by anticipating the needs of the clients and ensuring the alignment of the internal and external teams focused on the implementation.
Responsibilities and Duties:
Provide EBR consulting services to assigned projects as required, including product functional consulting, business process re-engineering, customization requirements, product validation and custom report analysis.
Provide EBR Product training to customers as required on the modules that the Sr. Consultant is certified in.
Continue to improve knowledge of CQ’s solution, quality standards, industry, and technology to better serve the internal and external customers.
Proactively improve one’s productivity and quality.
Participate in refresher training classes to renew certification and new training classes for new products, quality standards, industry, and technology.
Provide EBR product and industry training to company employees as assigned.
Timely and quality delivery of project deliverables in accordance with the project’s
schedule and timeline under the direction of the project manager.
Escalate any issues that cannot be immediately resolved to the project manager in charge of the team.
Ensure that appropriate reports are written for all the appropriate deliverables.
To mentor, coach, and guide EBR Solution Consultants
Maintain current on all assigned internal CQ training as assigned in the CQ-QMS.
Comply with all internal CQ Quality and Information Security requirements.
Requirements/ Qualifications:
Bachelors (Masters preferred) in Engineering, Computer Science, Life Sciences, or related field
5+ years of experience in Pharmaceutical, Biotech, Medical Devices Manufacturing supporting the design and sustainment of Electronic Batch Records (EBR).
Familiar with Manufacturing Execution System (MES) platforms (e.g., MasterControl MX, Tuliop, Werum PAS-X, Emerson Syncade, Siments Opcenter).
Experience in GMP, GAMP 5, and regulatory compliance frameworks.
Knowledge of FDA 21 CFR Part 11, EU Annex 11, and other relevant regulatory guidelines.
Ability to conduct design sessions and provide training.
Excellent verbal and written communication skills.
Preferred Qualifications:
Preferred – Project Management experience/PMP certification
Preferred – ASQ, Salesforce Admin certification