Senior Quality Training Specialist

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Summary

Located at our Indianapolis, IN facility, The Quality Training Specialist will be responsible for supporting the training management processes related to manufacturing and distribution of clinical trial and commercial products for RayzeBio programs. Responsibilities also include supporting implementation of and adherence to the quality procedures. Additionally, the Quality Training Specialist will become a subject matter expert (SME) in management related to quality systems. The Quality Systems team is responsible for enabling development and operations of the RayzeBio Indianapolis site by ensuring compliance to regulations and the Quality Management System (QMS).

Job Responsibilities

Essential duties and responsibilities include the following.  Other duties may be assigned.

• Assist with the implementation of the RayzeBio Training Management program

• Setup new users in electronic Quality Management System (eQMS)

• Maintain training matrices for all site roles in coordination with department leaders

• Assign new eQMS users with training courses as required per the training matrices

• Organizing instructor led training courses with site SME instructors

• Update eQMS users with training courses as required when changing roles

• Inactivate uses in eQMS when they leave the company

• Ensure that Trainers/Instructors have documented expert training evidence or ‘train-the-trainer’ justification in their training records

• Participate in establishing training best practices and processes to build a comprehensive on-the-job training program

• Working with Human Resources to ensure all site personnel maintain updated job descriptions and resumes at least annually

• Coordinate recertification of personnel for required testing such as vision screening

• Manage, organize and maintain all site personnel training records electronically and/or physically

• Assist with the establishment of policies and standard operating procedures to ensure compliance with GXP regulations as required

• Assist with continuous improvement projects to improve the Training Management program

• Provide tactile support with the day-to-day processes focused on KPIs to ensure compliance and on-time completion of all required training

• Build strong partnership and collaboration with internal stakeholders such as R&D, Production, Engineering, QC, QA, EHS and Human Resources to drive and align on agendas and priorities

• Support audits as a SME of the Training Management Program and/or provide requested training records for auditors

Long-term:

•            Support the efforts to commercialize the distribution of current clinical programs upon FDA approval

Education and Experience

·BS degree in related field (Education, HR, Science, Learning & Development preferred)

·2+ years of proven experience in a training role (cGMP experience preferred)

·Demonstrated working knowledge of quality management systems and learning management software (LMS)