GMP Training Specialist
Location: Lombard, IL, United States
Position Type: Unfixed Term
Job Function: Other
A world leader in the field of in vitro diagnostics for more than 60 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.
In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.
Description
- 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 of 1 year of experience in training development, ideally in an FDA-regulated setting.
- Instructional design or GMP-related certifications are preferred. OR
- 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
- 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.
- 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.
Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].
BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).
