Document Control & Training Specialist(18-Month Fixed-Term Contract)
About The Position
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. At Thermo Fisher Scientific, you'll be part of a team where your work directly supports the production of high-quality products that improve lives around the world. If you're passionate about quality, compliance, and continuous improvement, this is an exciting opportunity to make a meaningful impact while growing your career. This position is a 8-Month Fixed-Term Contract. As a Document Control & Training Specialist, you will serve as the site administrator and subject matter expert for our Electronic Document Management System (eDMS) and Learning Management System (LMS). You'll play a critical role in maintaining compliant document and training processes that support manufacturing operations and ensure adherence to GMP regulations, corporate quality standards, and site procedures. Working collaboratively with Quality, Manufacturing, Engineering, and other cross-functional teams, you'll help drive operational excellence by managing controlled documentation, coordinating employee training, supporting regulatory inspections, and identifying continuous improvement opportunities that strengthen our Quality Management System.
Requirements
- Minimum 3 years of experience in pharmaceutical, biotechnology, manufacturing, quality assurance, or another GMP-regulated environment.
- Experience administering Quality Management Systems such as MasterControl, TrackWise, or equivalent electronic document management systems.
- Experience supporting document control, training administration, or quality systems.
- Knowledge of cGMP regulations and ISO standards.
- Experience with Learning Management Systems (LMS) and electronic Document Management Systems (eDMS).
- Strong technical writing and document management skills.
- Excellent organizational, analytical, and problem-solving abilities.
- Ability to manage multiple priorities while maintaining exceptional attention to detail.
- Strong verbal and written communication skills.
- Proficiency with Microsoft Office applications and quality management software.
- Ability to work independently while collaborating effectively with cross-functional teams.
- Demonstrated commitment to continuous improvement and operational excellence.
Nice To Haves
- Experience supporting internal or external audits is preferred.
Responsibilities
- Serve as the Site Administrator and subject matter expert for the site's eDMS and LMS.
- Manage document lifecycle activities including document preparation, review, approval, effective date assignment, training assignment, document inactivation, and curriculum maintenance.
- Administer training programs by creating courses, assigning curricula, verifying completion, maintaining learning records, and ensuring training compliance.
- Maintain eDMS and LMS in compliance with GMP regulations, corporate standards, and site procedures.
- Partner with cross-functional teams to support documentation and training requirements across manufacturing operations.
- Generate and analyze compliance reports and site metrics related to document management and employee training.
- Deliver instructor-led and system training for eDMS and LMS users.
- Author and revise Standard Operating Procedures (SOPs), Work Instructions (WIs), and other controlled documentation.
- Coordinate periodic reviews of GMP documents, SOPs, WIs, and training curricula.
- Drive continuous improvement initiatives using Practical Process Improvement (PPI) methodologies.
- Support internal, client, and regulatory audits by providing documentation and responding to audit observations.
- Ensure site documentation aligns with Corporate Quality Standards and document retention requirements.
- Support onsite and offsite archival, retrieval, and destruction of GMP documentation.
- Maintain a safe working environment while supporting compliance with all Environmental Health & Safety requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
