Senior Quality Training Specialist
Senior Quality Training Specialist
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1 Vacancy
Job Description
Working with Us
Challenging. Meaningful. Lifechanging. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside highachieving 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: 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 trainthetrainer justification in their training records
Participate in establishing training best practices and processes to build a comprehensive onthejob 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 daytoday processes focused on KPIs to ensure compliance and ontime 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
Longterm:
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)
Demonstrated working knowledge of working in a cGMP facility (preferred)
Demonstrated experience in managing a training program for 50 employees
Skills and Qualifications
Possess the ability to manage multiple priorities in related disciplines to meet goals
Demonstrated knowledge in cGMP processes and training record requirements
Excellent professional ethics integrity and ability to maintain confidential information
Highly motivated and organized professional with the ability to work under pressure while meeting corporate goals and objectives
Strong communication skills
#RayzeBio #LIOnsite
If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work Lifechanging Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.
Onsite Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes siteessential sitebydesign fieldbased and remotebydesign jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Siteessential roles require 100% of shifts onsite at your assigned facility. Sitebydesign roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For fieldbased and remotebydesign roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your wellbeing and the wellbeing of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid19 and keep up to date with Covid19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Required Experience:
Senior IC
Employment Type
Full-Time
