JOB SUMMARY

The Document Control Specialist serves as a function within the organization’s Quality Management System (QMS) carrying responsibility for ensuring the integrity, control, traceability, and regulatory compliance of all controlled documentation supporting clinical research operations such as Policies, Standard Operating Procedures, Work Instructions, Templates, Forms, and Training Materials. 

This role operates within quality assurance, regulatory compliance, and operational execution while ensuring that all documentation managed by this role meets requirements of Good Clinical Practices, Quality Management System mechanisms, and applicable global regulatory expectations. 

The Document Control Specialist will also assist in the management process of electronic Quality Systems such as Training Management System (TMS) and Veeva Quality Issues & CAPAs and Audits modules. 

RESPONSIBILITIES

• Administer Clinilabs’ document control system to ensure all GxP documentation such as Policies, Standard Operating Procedures, Work Instructions, Templates, Forms, and Training Materials are created, reviewed, approved, distributed, and archived in accordance with established procedures. 
• Maintain document version control, ensuring only current, approved versions are available for use and obsolete versions are appropriately archived and restricted. 
• Manage and ensure execution of document review and approval workflows while ensuring appropriate functional and quality assurance review prior to issuance. 
• Track periodic reviews of documents in conjunction with process owners while verifying completeness, formatting consistency, and compliance of documents with internal templates and regulatory expectations. 
• Ensure document control practices comply with various global standards and guidance such as Food and Drug Administration (FDA). European Medicines Agency (EMA), International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, International Organization for Standardization (ISO), and ALCOA ++ principles. 
• Manage user access, permissions, and role-based controls in alignment with segregation of duties and data integrity principles with Quality owned software programs such as Training Management System (TMS) and Veeva. 
• Support internal audits, inspection readiness activities, sponsor audits, regulatory inspections, and various other activities by supporting quality and operations teams respectively. 
• Identify, document, and escalate document control deviations and support Quality Issue/ CAPA processes related with various documentation types as part of Clinical Research. 

Salary Range: $75,000–$82,000 annually. Final compensation is based on experience, location, and overall expertise.    

TRAVELING

Travelling will not be required for this role. Periodic visits to Headquarters in Eatontown, NJ as needed. 

• Bachelor’s degree in relevant area and knowledge on quality management systems such as document control, or equivalent combination of education and experience that provide the skills and knowledge to successfully execute job requirements. 
• The ability to work independently while maintaining sufficient tracking mechanisms to ensure various documentation activities are coordinated, approved, and closure of all subsequent activities. 
• Ability to work and communicate effectively across various inter-departmental domains including Clinical Research Unit, Global Clinical Operations, Clinical Data Management, Quality and Regulatory Compliance, Information Technology, Finance, Commercial Development, Human Resources, and Executive Management.
• Approximately >/= 5 years of experience in Quality Management Systems and previous experience controlling document life-cycle processes; has worked in a Good Clinical Practice environment. 
• Experience in working within computerized systems while maintaining principles of data integrity, audit trails, and ALCOA++ principles.