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Training Specialist

Kelly Services

Rockville, MD
Job Code:
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Job Details

Job Title Training Specialist

Jobid US51FPDS_BH1430061

Location: Rockville, MD, 20851, USA

Description Kelly Scientific Resources has an opening for a Training Specialist in Rockville, MD that will be responsible for administering and maintaining the Quality Management System (QMS) Training Program in accordance with applicable medical device regulations and standards, including FDA 21 CFR Part 820 and ISO 13485:2016. This position will be responsible for developing and conducting GMP and QMS training for the company, and implementing and managing the electronic Learning Management System (eLMS) including end-user support.


+ Developing, scheduling and conducting GMP and QMS training, including good documentation practices (GDP) training, for all personnel upon hire and annually.
+ This position owns the GMP and QMS training materials and ensures content is current and in compliance with applicable medical device regulations and standards (e.g. FDA QSR, ISO 13485) and internal procedures.
+ Developing materials for and conducting Train the Trainer courses for designated employees.
+ Working cross-functionally with managers and supervisors to determine training requirements and establish and maintain training curricula at the department and individual level.
+ Working with Project Leads to determine required QMS and GMP training for project-specific personnel involved in medical device and IVD projects.
+ Proactively works with managers and supervisors to determine training requirements for all created roles and positions.
+ Administering and maintaining the eLMS, including assisting end users with troubleshooting issues.
+ Assisting managers and supervisors in determining the need for new and refresher training, and disseminating training notifications to employees.
+ Developing materials for and conducting end-user training for the use of the eLMS for all employees.
+ Owning and authoring/revising training-related QMS policies, procedures and work instructions, ensuring continued process improvement and maintaining compliance to applicable medical device regulations and standards.
+ Creating, maintaining and optimizing personnel training files, including filing of hardcopy training documentation and managing secured storage.
+ Monitoring and tracking required training, providing notification to applicable management regarding training deficiencies.
+ Reporting to Quality Management on the status of training metrics at defined intervals.
+ In the absence of an eLMS, this may be accomplished by updating and maintaining a manual training database.
+ Assisting trainers in the development of training content and evaluation materials appropriate for the GMP and/or QMS subject matter, if applicable.
+ Supporting internal audits and external inspections by maintaining organized and accurate training files and facilitating the timely retrieval of requested documentation related to training.
Qualifications and Skills:

+ Minimum of a Bachelor’s degree, with preference given to those in basic (e.g. biology, chemistry, physics, etc.) or life (e.g. physiology, human biology, etc.) sciences.
+ Minimum of 3 years' experience in a training role or other quality-related function in a medical device or other regulated/GMP environment. Preference will be given to candidates with prior experience establishing and implementing QMS/GMP training requirements and curricula.
+ Working knowledge of current Good Manufacturing Practices (GMP), 21 CFR Part 820 and ISO 13485:2016.
+ Experience administering and/or using an eLMS, with preference given to candidates who have assisted in the implementation of an eLMS.
+ Prior experience developing and conducting training, most notably QMS/GMP training.
+ Prior experience supporting and/or participating in compliance audits or inspections.
+ Candidate must have strong attention to detail and have the ability to manage multiple priorities.
+ Highly effective written and spoken communication skills are required. Candidate must be able to adapt training style to accommodate audience skill levels
+ Must be proficient in the use of a PC and Microsoft Office tools including Word, PowerPoint, Excel and Visio
**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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