The Document Control Training Coordinator will be responsible for a wide variety of activities pertaining to Quality Assurance, Records Management, Training and improving the overall Quality System. This role will be responsible for the processing and maintaining of GMP and GDP documentation throughout their lifecycle and for supporting TMDX’s training program.
Responsibilities:
- Assist Document Control Manager with Document Control PLM electronic training system and hard files in support of other departments, in accordance with policies and procedures.
- Support the operation and improvement of TMDX Training Program including creating/adding curriculum assignments in training system, creating and distributing training reports, and partnering cross functionally to provide first line training support.
- Act as the SME for the electronic training management system, providing training/support for system users.
- Promote TMDX quality and compliance mindset throughout the organization by demonstrating the capabilities of the training and documentation management systems.
- Ensure training records are accurate and timely.
- Manage TMDX Training calendar.
- Internal reporting for various department training system metrics.
- Ensure accuracy, quality, and integrity of all company documents.
- Ensure easy and efficient retrieval of training documentation internally and externally as well as archival of training documentation.
- Provide Document Control and training support during Audits/Inspections.
- Ensure ethics and compliance commitment at all times.
- Maintain confidentiality regarding sensitive documentation.
- Review and update associated documents for maintenance and quality control with being audit ready as the goal
- Maintain company documentation, as required.
- Perform other TransMedics job-related tasks and duties, as assigned
Experience:
- 3+ years’ experience working in a regulated industry; Med Device preferred.
- Direct experience in training, document control, and/or quality systems.
- Familiarity with a quality management system or other regulated environment and the ability to adhere to all processes and procedures.
- Experience in an electronic PLM system and/or electronic training system.
- Knowledge of US and EU cGMP regulations and guidance preferred.
- Proven mindset of proactive continuous improvements.
- Proficient with Microsoft Office suite.
- Strong organizational skills with the ability to work with a high degree of accuracy and independence.
- Strong attention to detail.
- Commitment to compliance and ethical standards.
- Excellent interpersonal, verbal, and written communication skills. Ability to communicate effectively with all members of the company including delivering presentations/training.
Education:
- Bachelor’s degree or equivalent education / experience gained through work experience.
