GMP Procedures and Training Specialist

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Facilitate management of procedures program with communications, process and application support.Facilitate assignments and updates of training items in the learning management system.Coordinate the alignment of procedure effectiveness and training assignment.Prepare reports and metrics on procedures and training.Provide support to SME and approver with training and inquiries on various applications.Support department compliance as it pertains to procedures and training programs.Benchmark practices with different BMS teams and communities.

Description

Partner with procedures manager to run an efficient procedures management system with on time periodic reviews and defined processes.

Manage procedures lists with SME, reviewers, approvers, process steps and due dates.

Schedule procedure discussion meetings, prepare agenda and minutes.

Prepare procedural document management workflows for various types of documents in compliance with procedures and training.

Apply the Quality Management Document hierarchy in alignment with PD and department practices.

Complete all training on time and achieve required document or training administration role skills and responsibilities.

Maintain procedure title, type and numbering as per department practice.

Format procedural documents according to guidelines.

Train others on their roles in the procedural document process and application.

Create, update and extend training items and curricula assignments and due dates.

Assign procedural training and insure alignment of procedure effective date and training due date.

Report deviations to GMP procedures to functional and quality management.

Participate in best practice teams and or on procedures and training and bench mark to recommend changes as part of process continues improvement. Implement process changes after gaining support.

Adhere to BMS core behaviors, ethics and other GMP compliance requirements.

Highly experienced in preparation of various procedure types for GMP testing and operations.

Able to recommend procedural format appropriate to application, content and user needs.

Knowledgeable in the requirements of management of procedures and documents in a GMP environment.

Requirements

At least 3 years’ experience in the use of validated document management system in a GXP environment.

Experience in GMP laboratory testing preferred.

Experience with selection and use of multiple document workflows and various roles of contributors to documents.

Ability to manage multiple priorities.

Effective communications skills - l written and verbal.

Ability to tell when something is wrong or is likely to go wrong and to communicate concerns and suggest resolution.

Must be a team player willing to speak up and to fully support the team approved direction.

Expert level experience in Microsoft word, routine user of Excel and owner level for SharePoint Online.

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com