Job Details

Position Summary
The Specialist, Document Management & Training is responsible for supporting the administration and continuous improvement of the document control and training systems within a GMP-regulated environment. This role ensures that controlled documents and training records are accurate, compliant, and maintained in accordance with regulatory requirements and internal procedures.
The Specialist will partner cross-functionally to manage document lifecycles, support training compliance, and drive timely completion of training assignments, while contributing to operational excellence and inspection readiness initiatives.

Responsibilities
*Support day-to-day Document Control and Training processes.
*Assist with the development and implementation of controlled documents including, but not limited to: SOPs, Work Instructions, training materials, protocols, reports, templates, and reference guides.
*Execute against enterprise formatting/authoring standards and ensure all documentation is formatted accordingly. Formatting may include creating templates, fonts and style, pagination and numbering and any other activities required to achieve document requirements. 
*Track and drive timely periodic review and approval of documents. 
*Create and maintain training requirements and training plans in the eLMS.
*Generate compliance metrics and prepare routine KPI reports for Document Control and Training processes.
*Ensure training compliance by monitoring completion of required training and following up with stakeholders as needed. 
*Build and maintain relationships with other departments and establish a culture of engagement and transparency with Quality.
*Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
*Perform other duties, as assigned.

Qualifications
*Bachelor’s degree in Computer Science, Life Science or related field or applicable experience.
*2+ years in Quality Systems/Quality Assurance experience in the regulated life sciences industry.
*Experience in the use of validated computer systems for management of regulated documents and training, including electronic records and electronic signatures.
*Thorough knowledge of electronic Quality Management Systems, Learning Management Systems and Quality Documentation Systems, admin experience strongly desired.
*Experience with Dot Compliance, preferred. 
*Experience developing improvements to electronic Quality Systems.
*Strong software proficiency with Microsoft Suite and other desktop applications.
*Ability to manage multiple projects in a dynamic environment with attention to detail.
*A well organized, self-motivated and independent work style with the ability to initiate and follow through on expected duties.
*Excellent written and verbal communication and collaboration skills with the ability to interact with all levels throughout the organization.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

Pay ranges between 50-60/hr based on experience