- Training Program Development:
- Design, develop, and update training programs focused on CGMP principles, regulations, and industry best practices.
- Create training content, including presentations, e-learning modules, SOPs, and job aids, as necessary.
- Collaborate with subject matter experts (SMEs) to ensure accurate, relevant and timely training materials.
- Training Delivery:
- Conduct training sessions for new hires, existing employees, and contractors.
- Deliver training in various formats, such as classroom sessions, virtual training, and on-the-job coaching.
- Customize training based on specific roles (e.g., manufacturing, quality control, laboratory).
- Compliance and Documentation:
- Ensure that all training records are accurately maintained and up-to-date.
- Monitor employee compliance with training requirements.
- Assist in audits and inspections related to training documentation.
- Continuous Improvement:
- Evaluate training effectiveness and make necessary adjustments.
- Identify areas for improvement and propose enhancements to training programs.
- Stay informed about industry trends, regulatory changes, and advancements in CGMP practices.
- Collaboration:
- Work closely with Quality Assurance, Regulatory Affairs, Manufacturing, and other departments to align training initiatives with business goals.
- Coordinate with external training providers or consultants when needed.
- Evaluate training effectiveness and adjust programs as needed to meet evolving quality and other organizational goals.
- Must have the ability to be able to explain complex topics in an understandable format.
- Self-motivated, highly collaborative
- Ability to work with ambiguity and translate abstract ideas or visions into terms that a general audience can understand.
- Be perceptive to recognize when messages are not resonating or being understood.
- High level of professionalism and confidence to work effectively with employees from all levels of the organization, including senior leaders, functional managers, and the general employee population.
- Proven success in effective communication across all levels of the organization, with the ability to influence key stakeholders.
- Experience managing and resolving issues, risks, and conflicts.
- Demonstrated strong written and verbal communication skills required. Ability to communicate in fast-paced environment with frequent change and challenges requiring daily flexibility.
- Must be fluent in English and Spanish
- Bachelor's degree in a relevant field.
- Must be thoroughly familiar with applicable laws, regulations and guidances related to pharmaceutical CGMPs.
- Strong attention to detail,
- Strong analytical and problem-solving skills.
- Software Proficiency: Proficient in document management systems and Microsoft Office Suite.
- Communication Skills: Excellent written and verbal communication skills.
- Preferred 5+ years' work experience within a CGMP regulated pharmaceutical environment.
- Receive instructions through oral and written communications accurately and quickly.
- Convey answers or instructions to other workers accurately, loudly, and quickly.
- Must be able to lift and move up to a max. of 20 pounds.
- Employee will be subject to dust, noise, fumes and odors.
- The physical activity of this position includes, but is not limited to:
- Climbing, walking, stooping, kneeling, crouching, reaching, standing, pulling, lifting, grasping, twisting, sitting, feeling, and visual acuity
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Training Specialist - Lincoln, United States - Denison Pharmaceuticals
Description
Position Summary:The Training Specialist (Spanish) is responsible for designing, implementing, and managing training programs. This role ensures that employees receive the necessary training to comply with regulatory requirements (i.e., they are qualified for their job/task), maintain product quality, and uphold safety standards. The Training Specialist collaborates with cross-functional teams, develops training materials, and assesses training effectiveness.
Training Specialist (Spanish) Key Responsibilities:
*Please note we are NOT working with recruiters at this time.
*ALL positions are in-office.
