Document Control Specialist

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Document Control Specilalist

R-01352916

Pittsburgh, PA or Morrisville, NC Join Thermo Fisher Scientific in ensuring the highest quality standards across our operations. As a Quality Specialist III, you will maintain regulatory compliance and drive continuous improvement of quality systems to support our mission of enabling customers to make the world healthier, cleaner, and safer. The Document Control Specialist is responsible for managing and optimizing document control processes within the MasterControl Quality Management System (QMS). This role supports global operations by ensuring compliance, standardization, and efficiency across document lifecycle management, while collaborating with cross-functional teams to drive continuous improvement and system adoption.

Key Responsibilities:

Support the System Administrator with global user administration in MasterControl for approximately 4,000 users. Manage the development, implementation, and maintenance of end-to-end document control processes within MasterControl. Analyze business requirements, evaluate process and system design options, and identify opportunities for simplification, standardization, and automation. Support global deployment and adoption of standardized document control processes across field service organizations, minimizing customization where possible. Collaborate with global Field Service teams to ensure effective training on document control processes, policies, and systems. Lead and support policy governance activities to ensure ongoing compliance with internal and regulatory requirements. Maintain and support ERP systems related to document control and quality processes. Assist in system validation activities and compliance initiatives. Support the configuration, implementation, administration, and continuous improvement of the MasterControl QMS within the global IES division. Lead and execute projects related to regulatory documentation and quality processes, ensuring delivery against defined timelines.

Requirements:

Bachelor's degree required preferably in a relevant field (e.g., Life Sciences, Engineering, Quality, or Business).

Required:

Hands-on experience with MasterControl QMS (administration, document control, or configuration). Experience in document control, quality systems, or within a regulated industry (e.g., FDA, ISO). Strong understanding of document lifecycle management and compliance requirements. Experience supporting global or cross-functional teams. Familiarity with ERP systems and validation processes is preferred. Strong analytical and problem-solving skills with attention to detail. Excellent verbal and written communication skills. Strong interpersonal skills with the ability to collaborate across functions and organizational levels. Proficiency with quality systems software, including MasterControl and document control systems. Ability to work independently while contributing to cross-functional initiatives.

Preferred Skills:

Experience with process improvement and automation initiatives. Knowledge of regulatory requirements in life sciences or similar industries. Ability to support multiple projects and collaborate with global stakeholders.