Training Coordinator
3 days ago
Job Title: Training Coordinator
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Location: Princeton, NJ
Duration: 1 year contract
Must Haves/Requirements:
Top 3-4 Skills/Experience:
Excel skills are less important than for the last project phase, add the experience working with cross-functional and international teams. This role will interface with Europe, South America and possibly Asian based teams.
This will include the possibility of having to coordinate meetings in local time zones.
- At least 1-2 years of equivalent experience in an FDA regulated environment.
- Prefer at least 1 year of experience in a Training Management or Documentation Support role
- Working knowledge of medical device regulations, FDA Code of Federal Regulations (CFR), Title 21, Part 820, Quality System Regulation, ISO13485 & MDSAP
- An organized, analytical thinker with exceptional attention to detail
- An excellent communicator, both oral and written
- Experience with Electronic Document and Training management systems.
- Working knowledge of Windows and Share Point; good Excel skills.
- Able to manage multiple projects and meet project deadlines.
- Experience working cross-functionally and with international teams.
Responsibilities:
- Work cross-functionally to determine necessary training for functions/roles and assist in the continuous improvement of the corporate quality management system.
- Support training and provide guidance to colleagues on how to utilize C&D systems.
- Maintain document control activities per SOP and regulatory guidelines.
- Facilitate development and/or updates to workflows, policies and procedures to govern quality processes.
- Provide support in the roll-out of company quality standards.
- Develop training material and deliver training.
- Facilitate the resolution of any document control and training discrepancies or issues (escalate as necessary)
- Provide guidance to managers on how to build, utilize and maintain training matrix.
- Facilitate the resolution of training discrepancies or issues (escalate as necessary).
- Support tracking of training KPI.
- Participate in PTC Roundtable calls and community of practice.
Secondary
- Support development and improvement of quality management documentation.
- Support development of training modules.
- Support development and/or updates of workflows, policies and procedures.
- Other duties as required.
Requirements:
- At least 1-2 years of equivalent experience in an FDA regulated environment.
- Prefer at least 1 year of experience in a Training Management or Documentation Support role
- Working knowledge of medical device regulations, FDA Code of Federal Regulations (CFR), Title 21, Part 820, Quality System Regulation, ISO13485 & MDSAP
- An organized, analytical thinker with exceptional attention to detail
- An excellent communicator, both oral and written
- Experience with Electronic Document and Training management systems.
- Working knowledge of Windows and Share Point; good Excel skills.
- Able to manage multiple projects and meet project deadlines.
- Experience working cross-functionally and with international teams.
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