Job details

GMP Training Specialist

The GMP Training Specialist plays a pivotal role in developing, delivering, and maintaining effective training programs that ensure regulatory compliance and operational excellence at our Lombard, IL manufacturing site. This position collaborates closely with departments such as Quality, Manufacturing, and a regional training team to align training initiatives with evolving compliance requirements. The ideal candidate will be skilled at balancing hands-on training with strategic program management, ensuring seamless integration of training programs across all shifts.

This role focuses on maintaining compliance with FDA, ISO 13485, ISO 9001, ISO 14001, and ISO 45001 standards, leveraging the ComplianceWire Learning Management System (LMS) to manage qualification pathways. Success in this role will be measured through training compliance rates, timely completion of change management tasks, reduction in deviations, and successful project execution.

Job Responsibilities:

Training Program Development and Delivery

Develop and maintain engaging, multi-modal training materials, including on-the-job guides, eLearning modules, instructional videos, and job aids.
Deliver in-person and virtual training sessions across shifts, ensuring engagement and knowledge transfer, including on the shop floor, conference rooms, and during off-hours when needed.
Coordinate with Quality and Manufacturing teams to update training content in response to change controls, deviations, and regulatory updates.
Collaborate with curriculum owners and managers to validate, revise, and align training curricula with evolving operational and compliance needs.

Compliance and Systems Management
Navigate and maintain the ComplianceWire LMS, ensuring all on-the-job, instructor-led, and eLearning training sessions are documented and mapped to employee qualification requirements.
Ensure alignment with regulatory standards (FDA, ISO 13485, ISO 9001, ISO 14001/45001) and internal quality systems.
Monitor and report training compliance rates, identifying and resolving gaps to maintain audit readiness.
Project Management and Cross-Functional Collaboration
Manage multiple concurrent training projects, ensuring timely execution and stakeholder communication.
Collaborate with a regional training team to align local training initiatives with broader corporate strategies.
Provide input into change management initiatives to ensure training materials remain current and effective.
Support continuous improvement initiatives by identifying training-related solutions to reduce deviations and enhance compliance.

Minimum Requirements:

Bachelor’s Degree (in Education, Life Sciences, or a related field):

Minimum of 1 year of experience in training development, ideally in an FDA-regulated setting.
Instructional design or GMP-related certifications are preferred. OR

Associate’s Degree:

Minimum of 3 years of experience in training development within a regulated manufacturing environment.
Certifications such as GMP Professional or ComplianceWire LMS are a plus. OR

High School Diploma or GED:

Minimum of 5 years of experience in training development, preferably in a GMP/GxP environment.
Relevant certifications (e.g., CPTM, CQIA, CID) are highly desirable.

Technical Knowledge and Skills

Proficiency in Microsoft Office (Word, Excel, PowerPoint) and experience with LMS platforms, particularly ComplianceWire.
Strong understanding of GMP, Good Documentation Practices, and quality systems (ISO 13485, ISO 9001, ISO 14001/45001).
Familiarity with instructional design tools (e.g., Articulate 360, Adobe Captivate) and multimedia training methods.
Exceptional project management skills with the ability to manage multiple priorities in a fast-paced environment.
Interpersonal and Organizational Skills
Excellent verbal and written communication skills, with the ability to present complex information to a non-technical audience.
Ability to work independently, manage time effectively, and adapt to shifting priorities.
Demonstrated problem-solving skills and a proactive, self-starter mindset.

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CEO of bioMérieux

Pierre BOULUD

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Average salary estimate

$70000 / YEARLY (est.)

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$60000K

$80000K

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What You Should Know About GMP Training Specialist, bioMérieux

As a GMP Training Specialist at our dynamic manufacturing site in Lombard, IL, you will be at the forefront of developing and implementing training programs designed to drive regulatory compliance and operational excellence. This role offers a unique blend of hands-on training and strategic program management, empowering you to engage with various departments, such as Quality and Manufacturing. Your mission will be to ensure that training initiatives align seamlessly with evolving compliance requirements, including FDA and ISO standards. You'll craft and deliver engaging training content that includes eLearning modules, instructional videos, and on-the-job guides. Your expertise in the ComplianceWire Learning Management System will be crucial, as you ensure thorough documentation and effective tracking of employee qualifications. You'll monitor training compliance rates, manage multiple projects concurrently, and collaborate with our regional training team to align local initiatives with corporate strategies. If you have a passion for education and a desire to foster a culture of continuous improvement, this is the perfect opportunity for you. Join us and be part of a team that values quality and compliance, ensuring that every employee is equipped with the knowledge they need to succeed.

Frequently Asked Questions (FAQs) for GMP Training Specialist Role at bioMérieux

What is the role of a GMP Training Specialist at the company?

The GMP Training Specialist at our company plays a critical role in developing and delivering training programs that ensure compliance with FDA regulations and various ISO standards. This position involves close collaboration with multiple departments, allowing you to impact operational excellence significantly.