Job Description
Job Description
Job Description
Salary:
Purpose
The Training and Documentation Coordinator will support the Senior Change Manager in the execution and maintenance of the organizational training program and document management processes.
Responsibilities
- Develop and maintain Training Matrixes in accordance with training procedures
- Support the Senior Change Manager in implementing and maintaining training compliance and record management processes
- Collaborate with subject matter experts and internal teams to understand complex processes and support the development of accurate training materials and workflows
- Support the coordination and management of onboarding and recurring employee training assignments across multiple business units
- Manage and maintain control of document storage, archival, and retrieval in accordance with standard operating procedures and regulatory requirements
- Obtain in-depth understanding of processes to support accurate development of process, product, and technical documentation requirements
- Maintain a working knowledge of change management and quality processes and procedures
- Support the Senior Change Manager in collecting, analyzing, and reporting data related to training compliance, documentation activity, and quality metrics to identify trends, support KPI tracking, and drive continuous improvement initiatives
- Support internal and external audits by ensuring training and recordkeeping documentation is complete, current, and accessible
- Provide support in periodic reviews of controlled documents
- Assist in maintaining the SOP table of contents, master label list, equipment list, signature log, training matrix, and quality event log
- Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures. Provide support and working knowledge of internal policies to effectively assist others and educate others within the organization
- Start job duties on time, stay on the job throughout the assigned shift to complete duties properly, and attend all scheduled meetings and appointments. Ensure completion of assigned tasks and responsibilities within defined timeframes
- Maintain flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary
- Perform other duties as assigned
Skills
- Ability to work independently and in a team environment
- Excellent attention to detail and organization
- Excellent written and verbal communication
- Highest level of ethics and integrity
- Ability to lead and motivate the right behaviors
- Ability to multi-task and work in a fast-paced environment
- Strong technical writing
- Effective project management
- Proficiency in Microsoft Office
- Strong analytical thinking
Qualifications/Requirements
- Bachelors degree in Life Sciences, Education, Quality Assurance, Business Administration, or a related field required
- 12 years of experience in training coordination, documentation management, or recordkeepingpreferably in a regulated or quality-driven environment
- At least 1 year of experience in an FDA regulated industry for quality preferred
- Clearance of favorable background investigation required
Job Tags
Work at office, Shift work, Weekend work, Weekday work,