At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Bristol-Myers Squibb in Phoenix, Arizona is searching for a remarkable GMP Training Specialist to join our phenomenal team! As our GMP Training Specialist, you will be g is responsible for the successful design, development, and implementation of Good Manufacturing Practices (GMP) training. This position is responsible for the accurate and timely processing of all training requests in the Learning Management System (LMS) and Document Management System (DMS). This position collaborates with department managers to maintain current and accurate training curricula and assignments. The Specialist is responsible for communicating with department managers to ensure all site employees maintain a GMP-compliant process. Provides technical support to the business as required to use the LMS and electronic training request systems. The Specialist provides training solutions that adhere to the Site Training procedure. The Specialist evaluates GMP training needs, implements project plans, teaches and supports training events.
Required Competencies: Knowledge, Skills, and Abilities
Intermediate knowledge of GMP regulations, particularly those pertaining to training, personnel, and good documentation practices.
Intermediate knowledge of quality systems and ability to navigate the LMS and DMS.
Ability to use instructional design systems to develop, implement, and facilitate training.
Intermediate knowledge of working with computerized systems.
Intermediate skills in using MS Outlook, Word, Excel, and PowerPoint.
Ability to communicate training processes, issues, and resolutions with a high-level of accuracy to all personnel levels.
Intermediate organizational and time management skills.
Intermediate technical writing skills.
Duties and Responsibilities
Performs day-to-day functions to support the GMP Training department processes.
Administers and troubleshoots the electronic LMS and training management request system.
Processes and verifies all electronic and paper training records.
Creates, manages, and assigns training plans for all site GMP employees.
Creates and maintains user groups, curricula, and training items within the LMS.
Provides reports/queries/metrics as requested from LMS for compliance.
Recognizes and resolves training discrepancies. Communicates occurrences and corrective actions to management and affected personnel.
Verifies and approves accuracy of training information within the quality systems.
Maintain training records for all personnel according to regulatory and document retention requirements.
Facilitates and supports the Train-The-Trainer instructor-led courses to establish Qualified Trainers.
Facilitates and supports the Annual GMP program and New Hire Onboarding Training program
Provides backup training for additional topics for cross-functional departments when needed.
Works with department managers on an ongoing basis to implement GMP training goals.
Assists in developing training using a mix of training methods, including instructor-led, on-the-job, and other blended learning.
Assists with the creation and revision of training materials.
Reports on training compliance and creates additional training reports to assists managers with monitoring department training.
Collaborates with the documentation group to conduct training impact assessments and ensure accurate training assignments for new and revised controlled documents.
Supports site inspections and audits for training-related requests.
Performs all other tasks as assigned.
Education and Experience
Bachelor’s degree preferred.
Five years of relevant work experience required, preferably in a regulated pharmaceutical environment.
Experience using eLearning design tools (Articulate 360) is preferred.
Experience using LMS systems (ComplianceWire and SuccessFactors) is a plus.
Experience using DMS systems (Veeva) is a plus.
Experience using Adobe Cloud applications is a plus.
An equivalent combination of education and experience may substitute.
Working Conditions
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
BMSBL
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Job ID: 41138
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