Description 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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bioMerieux Inc.
Nov 25, 2024