Job Details

Key Responsibilities​

• Support implementation of document control and training management systems, including configuration of document types, workflows, lifecycles, and role-based access. 

• Assist in configuring training assignment rules, curricula, and completion tracking within the training management system. 

• Participate in requirements-gathering workshops and translate business needs into system configuration specifications. 

• Develop and execute test scripts to support system validation, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities as applicable. 

• Support data migration activities, including mapping and validating legacy document and training records into the new system. 

• Draft and maintain project documentation such as configuration specifications, test scripts, standard operating procedures (SOPs), and training materials. 

• Assist with end-user training delivery and development of job aids/quick reference guides. 

• Support change management activities, including communication planning and stakeholder readiness assessments. 

• Collaborate with quality, regulatory, and IT stakeholders to ensure configurations align with GxP and 21 CFR Part 11 requirements. 

• Escalate risks, issues, and open items to the project lead in a timely manner. 

​

Required Qualifications

• 3-6 years of experience supporting document control and/or training management system implementations, ideally within the life sciences, pharmaceutical, biotech, or medical device industry. 

• Working knowledge of document control processes (authoring, review, approval, periodic review, retirement) and training management processes (curricula, assignments, effectiveness checks). 

• Familiarity with GxP requirements and computer system validation (CSV) or Computer Software Assurance (CSA) practices. 

• Experience writing and executing test scripts in a validated environment. 

• Strong written and verbal communication skills, with the ability to produce clear documentation. 

• Comfortable working directly with client stakeholders in a consulting environment. 

• Proficiency with Microsoft Office/Excel; experience with quality or document management platforms (e.g., Veeva, MasterControl, TrackWise, SharePoint-based QMS tools) is a plus. 

​

Preferred Qualifications

• Exposure to data migration activities from legacy document/training systems. 

• Familiarity with change management frameworks and end-user training/adoption approaches. 

• Bachelor's degree in a relevant field (life sciences, quality, engineering, information systems, or related discipline). 

Success in the Role

The successful candidate will independently execute assigned validation activities, produce high-quality validation documentation, identify issues early, and work effectively with client Engineering, Quality, Operations, Facilities, and IT organizations. 

Work Authorization
Qualified applicants must be authorized to work in the United States on a full-time basis. HbSage will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.