Specialist, Training

POSITION SUMMARY

ESSENTIAL JOB FUNCTIONS & DUTIES

• Develop, implement, and maintain the company’s training program in accordance with FDA, cGMP, and company policies.

• Conduct training needs assessments and collaborate with department heads to identify required competencies and skill gaps.

• Develop and update training materials, including SOPs, presentations, manuals, and job-specific content.

• Deliver training sessions for new hires, refresher courses, and role-specific programs across departments.

• Maintain accurate and current training records in the Learning Management System (LMS) or other databases.

• Monitor employee training status and issue reminders to ensure timely completion of required courses.

• Prepare and distribute training reports for management and regulatory audits.

• Coordinate and facilitate onboarding and orientation programs for new employees.

• Support Quality Assurance in ensuring personnel training meets cGMP and FDA compliance standards.

• Conduct evaluations to measure training effectiveness and make improvements based on feedback and performance results.

• Assist in developing competency matrices, training schedules, and certification programs.

• Collaborate with internal subject matter experts to design and implement technical and compliance-based training modules.

• Participate in internal and external audits by providing training documentation and responding to auditor inquiries.

• Support the creation and maintenance of training SOPs and controlled documents.

• Promote a culture of continuous learning and professional growth throughout the organization.

REQUIRED QUALIFICATIONS, EDUCATION, AND EXPERIENCE

• Bachelor’s degree in Education, Human Resources, Quality Management, or related field preferred.

• 3–5 years of experience in training coordination, learning and development, or quality compliance, preferably within dietary supplement, food, or pharmaceutical manufacturing.

• Strong understanding of FDA 21 CFR Part 111, cGMP, and regulatory training requirements.

• Experience developing and delivering training programs in both classroom and virtual settings.

• Proficiency with Learning Management Systems (LMS) and Microsoft Office Suite (Word, Excel, PowerPoint).

• Excellent organizational, communication, and presentation skills.

• Strong attention to detail and ability to maintain accurate training documentation.

• Ability to manage multiple training programs and priorities simultaneously.

• Knowledge of adult learning principles and instructional design techniques preferred.

• Certification in training or instructional design (e.g., CPTM, ATD) a plus.