What are the responsibilities and job description for the Specialist, Training position at FORMULIFE LLC?
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.
EMPLOYEE AND MANAGER cGMP RESPONSIBILITIES
Employee Responsibilities
- Adhere to cGMPs and SOPs.
- Report any situations that might harm food safety or quality immediately to the supervisor or QA Department.
- Ensure food safety and quality are maintained according to company standards.
- Comply with policies and procedures to prepare and pack products under sanitary conditions that do not expose it to the risk of contamination.
- Operate and maintain a clean and hygienic standard of operation. Always Follow Company CGMPS (Current Good Manufacturing Practices and Food Safety Policies).
Supervisor Responsibilities
- Maintain a Food Safety Culture by regularly assessing the team’s performance and understanding of food safety practices.
- Initiate decisions on corrective action that support resolution and improved policies and procedures.
- Communicate to employees any opportunity to improve team performance to achieve greater levels of product safety and quality.
- Comply with policies and procedures to prepare and pack the product under sanitary conditions that do not expose it to the risk of contamination.
- Encourage and maintain a strong food safety culture by ensuring employees are knowledgeable of food safety policies and procedures, as well as empowered to report events that could impact the food safety of the product
PHYSICAL DEMANDS
- Prolonged periods of sitting, standing, and computer work.
- Occasional walking, lifting, or moving materials up to 25 pounds.
- Manual dexterity for handling documents and electronic training equipment.
- Visual acuity for reviewing presentations, training materials, and records.
- Ability to deliver presentations and facilitate group discussions effectively.
WORK ENVIRONMENT
- Professional office setting within a manufacturing facility.
- Must adhere to company safety, confidentiality, and compliance standards.
- Fast-paced, collaborative environment requiring flexibility and multitasking.
- Frequent interaction with Production, Quality, and HR teams.
- Occasional visits to production or warehouse areas to conduct or observe training.
FOOD ALLERGEN NOTICE: This facility may contain the following allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soy- beans, and sesame.
EQUAL OPPORTUNITY EMPLOYER: We are an Equal Opportunity Employer and consider qualified applicants for employment without regard to race, ethnicity, national origin, sex, sexual orientation, gender, identity or expression, age, disability, religion, military or veteran status, or any other characteristics protected by law.
ELIGIBILITY AND RIGHT TO WORK: To be considered for this position, applicants must be eligible to work in the U.S. without the need for employer-sponsored visa or work permit. In compliance with federal law, all individuals hired will be required to verify their identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire. We are an E-Verify employer and use the E-Verify system to confirm your eligibility to work in the U.S.