QA EBR Lead

SUMMARY:

The QA Electronic Batch Record (EBR) Lead will be responsible for leading the implementation, validation, and ongoing maintenance of the Manufacturing Execution System (MES) and support applicable EBR systems within GMP operations. This role ensures the EBR system is compliant and efficient batch execution, documentation, and review. Serves as Subject-Matter-Expert (SME) between Quality, Operations, Validation and IT. Supports integration and validation features/functionality with other enterprise software systems.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The following is a list of minimum responsibilities related to the QA EBR Lead position. Other duties may also be assigned.

• Lead cross-functional implementation of MES/EBR across warehouse, production, and quality operations.
• Develop and execute system qualification deliverables in accordance with 21 CFR Part 11, EU Annex 11 and applicable regulation/standards to maintain data integrity.
• Provide QA oversight for configuration management, user access controls, and periodic system reviews.
• Conduct impact assessments and QA oversight during system configuration updates, upgrades, or patches to ensure continued validated state.
• Work with cross-functional teams to manage change controls, deviations, CAPAs, and periodic system reviews.
• Author, review, and maintain SOPs, Work Instructions, Validations Protocols and Risk Assessments for EBR processes.
• Support the integration of EBR functionality with related systems such as ERP, LIMS and QMS.
• Assist in establishing and maintaining a periodic internal audit program to verify ongoing compliance with data integrity and system validation expectations.
• Serve as QA system owner and technical SME for EBR, functionality, configuration and compliance.
• Lead comprehensive training programs for QA, Operations and supporting departments on EBR usage, data integrity, and GMP documentation requirements.
• Define, track and trend key performance indicators (KPIs) for EBR performance.
• Ensure adequate data is collected and trended for analysis during Management Review and Annual Product Review.
• Lead and participate in continuous improvement to enhance compliance and efficiency of the EBR system and ancillary processes.
• Participate in internal, regulatory and customer audits at the discretion of management.
  
  

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

SUPERVISORY RESPONSIBILITIES:

No direct reports.

PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:

Bachelor’s degree in Engineering, Computer Science, Life Science or related discipline with four (4) years related experience, or Associate’s degree in related discipline with six (6) years related experience.

Experience in inspection of pharmaceutical or related industry and knowledge of FDA regulations related to cGMP’s is required.

• Thorough knowledge of quality control/assurance and/or operations is preferred.
• Good written and oral communication skills are required.
• Good organizational and planning skills are required.
• Able to communicate and interact effectively with others
• Strong understanding of manufacturing processes, especially in regulated industries like pharmaceuticals.
• Experience with MES systems preferred.
• Experience with ERP systems.
• Knowledge of GMP and other relevant regulatory requirements.
• Proficiency in data management and analysis.
• Excellent communication, collaboration, and problem-solving skills.
• Ability to train and support users on new systems.
• Experience with electronic signatures and audit trails.
  
  

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The employee is required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The working environment is clean and not normally subject to hazardous environment or conditions.

DISCLAIMER:

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.