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Job details
Qualification
Bachelor's
Job ID
R-01361356
Job description
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Job Summary
The Lead Document Control Administrator is responsible for coordinating and overseeing daily document control activities to ensure the accuracy, integrity, and compliance of controlled documentation. This role serves as the subject matter expert (SME) for document control processes and electronic document management systems (EDMS), provides technical guidance to team members, partners with cross-functional departments, and drives continuous improvement while supporting quality and regulatory compliance.
Key Responsibilities
Coordinate daily document control activities to ensure timely processing of controlled documents.
Manage document creation, revision, approval, distribution, archival, and obsolescence.
Serve as the primary resource for document control procedures and EDMS functionality.
Maintain document accuracy, version control, and audit trails.
Provide technical guidance and mentorship to End Users.
Collaborate with Quality, Regulatory, Manufacturing, Engineering, and Operations.
Monitor document metrics and recommend process improvements.
Support internal, customer, and regulatory audits.
Ensure compliance with company policies and applicable regulations.
Participate in change control, CAPA, and quality system initiatives.
Support EDMS upgrades, testing, validation, and user training.
Generate reports and dashboards for document control performance.
Qualifications
Bachelor's degree in Business Administration, Life Sciences, Engineering, Quality, or related field.
3 years or more of document control or quality systems experience in a regulated industry.
Experience with Electronic Document Management Systems (EDMS).
Preferred Skills
Advanced knowledge of document control principles and document lifecycle management.
Experience with EDMS platforms such as MasterControl, Veeva, TrackWise Digital, SharePoint, or OpenText.
Strong understanding of Quality Management Systems (QMS).
Excellent organizational, communication, and problem-solving skills.
Proficiency with Microsoft Office Suite.
Preferred Knowledge
FDA 21 CFR Part 11
21 CFR Parts 820
ISO 9001 and/or ISO 13485
GMP, GDP, Change Control, CAPA, and Risk Management
Leadership Responsibilities
Provide day-to-day technical leadership and guidance.
Mentor and train team members.
Coordinate workload and priorities.
Promote best practices and continuous improvement.
Key Competencies
Technical Leadership
Attention to Detail
Quality & Compliance Focus
Collaboration
Communication
Continuous Improvement
Accountability
Required skills
document control, electronic document management systems, quality management systems, version control, audit trail management, change control, capa, mastercontrol, veeva, trackwise digital, sharepoint, opentext, gmp, gdp, fda 21 cfr part 11, iso 9001, iso 13485, risk management, process improvement, mentoring, technical leadership, microsoft office suite, report generation, dashboard generation
