The Quality Training Department's focus is to provide structure and support around the GxP training program to ensure that people have the training, education, and experience to successfully execture their job functions. The department reports through the CAR-T Quality Assurance group in Raritan NJ, part of Johnson and Johnson Innovative Medicines.

Position Summary:

Execution of the training program to ensure we are compliant and meeting the needs of the business. Responsible for ensuring that employees have the right training at the right time through curriculum and learning plan management. Collaborates with subject matter experts to create GXP content. Perform training audits to evaluate the health of the training system. Continuously work to improve the Quality Training System to meet the needs of the business and our regulators.

Key Responsibilities:

• Liaison with the Quality organization focusing on QA, Facilities, Document Control and Management, and LENTI

• Training Management

o Learning Plan management

§ Work with people leaders to ensure learning plans are appropriate

§ Ensure annual review of learning plans is completed

o Curriculum Management

§ Review curriculum requests with SME

§ Ensure periodic curriculum reviews are completed (every 2 years)

o Content Management

§ Work with SME's to complete the Training Needs Assessment (TNA)

§ Route content through the EDMS (Electronic Document Management System)

§ Ensure periodic curriculum reviews are completed (every 3 years)

• Training Metrics

o Provide training metrics

o Support the monthly Training Metrics Meeting

• Conduct Internal Training Audits (In collaboration with our Technical Trainers)

o Batch Record Audits in the MES system

o 15 Read and Understands a Day

o Personnel Audits

• Audit Support

o Provide support during internal and external regulatory audits

o Point of contact for the back room

o Speak with auditors as an SME of their area

• Provide investigation, root cause, and CAPA support as a Training SME

• Community of Practice member

• Quality Training Meetings member

• Content owners for Site GxP content

Qualifications

Education:

A minimum of a bachelor's or equivalent University degree is required.

Required:

• 0-2years relevant working experience.

• Experience with electronic systems such as Learning Management Systems

• Ability to be agile and dynamic in prioritization and execution

• Experience creating training content

• Experience with curriculum design and management

Preferred:

• Adult Learning Understanding - flexibility in relaying information depending on audience

• Previous GxP and/or operations experience

• Experience with regulatory agencies and audits

• Organization, Critical Thinking, and Communication skills

• Growth Mindset

Other:

The anticipated base pay range for this position is $63,000-$102,350.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:
• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

If you are a motivated individual who pays close attention to detail and has a passion for instructional design, and if you want to make a positive impact in the pharmaceutical industry, we encourage you to apply. Johnson & Johnson is dedicated to fostering a collaborative and inclusive environment where we value and acknowledge your ideas and contributions. We are committed to providing equal opportunities to all qualified individuals and strive to create a diverse workforce.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.