Job Title: eQMS Implementation Specialist
Department: Quality Assurance
Location: Somerset NJ

Position Summary:
The eQMS Implementation Specialist will support the Quality department in the planning, implementation, validation, and rollout of computerized quality management systems (eQMS). The Specialist will gain hands-on experience in deploying quality systems in a regulated cGMP environment, while contributing to continuous improvement efforts to enhance compliance, efficiency, and data integrity.

Key Responsibilities:

• Assist in developing and documenting User Requirements Specifications (URS), Functional Specifications (FS), and Validation Protocols (IQ/OQ/PQ).
  

• Participate in and document system validation activities, including authoring and executing PQ scripts.
  

• Coordinate and document meetings, action items, and project timelines with cross-functional teams.
  

• Support the migration from legacy systems to new platforms, ensuring complete and accurate documentation throughout all project phases.
  

• Organize and review system-related documentation for quality and regulatory alignment. Lead or assist with user training coordination and gather feedback for continuous improvement.
  

• Author and revise Standard Operating Procedures (SOPs) and Work Instructions (WIs) approximately 50% of the time will involve technical writing from scratch.
  

• Perform workflow and form configuration within the eQMS platform based on evolving business needs.
  

• Collaborate with IT, QA, and business stakeholders during system go-live and post-implementation support.
  

• Participate in risk assessments and impact analysis for system changes.
  

• Ensure alignment with global regulatory expectations for electronic systems (e.g., 21 CFR Part 11, EU Annex 11).
  

• Uphold data integrity principles and maintain compliance with cGMP and company policies. Adhere to all Environmental, Health, and Safety (EHS) responsibilities.

Qualifications:
Education & Experience:

• Bachelor’s degree in a scientific, engineering, or information technology field.
  

• Minimum 3+ years of experience in the pharmaceutical or biotech industry, particularly within a cGMP-compliant environment.
  

• Hands-on experience with technical writing, documentation control, and QA/regulatory compliance.
  

• Familiarity with Computerized System Validation (CSV) methodologies and lifecycle documentation.
  

• Experience writing and executing PQ scripts and contributing to validation reports.
  

• Proficient in authoring SOPs and system-related documentation from scratch.

Preferred Tools/Systems Experience:

• Exposure to systems such as MasterControl, TrackWise, ComplianceWire, or other eQMS platforms.
  

• Experience in system migration and managing documentation during system transitions is highly desirable.

Key Competencies:

• Strong technical writing and document management skills.
  

• Detail-oriented with a commitment to data integrity and regulatory compliance.
  

• Solid understanding of GMP, QA, and regulatory standards for computerized systems.

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