Associate Technical Writer (Deviation Assessment), CAR-T Manufacturing Technical Support

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 .

Summary The associate will collaborate with internal Manufacturing partners, such as but not limited to Manufacturing Science and Technology (MSAT), Warehouse, Environmental Health and Safety (EHS) and Quality groups to support the completion of improvement actions (Deviations, CAPAs, Change Control and Document updates). The associate will also be responsible for working with the Manufacturing Operations (MO) and Quality teams on CAPAs and Change Controls as needed and ensure on time implementation. Associates will write, revise, and review all related GMP documentation for S12 CAR T manufacturing documents. Duties/Responsibilities Deviations Attend alignment meetings. Ability to create and/or review already created QMS deviations, provide feedback when needed, and ensure timelines are met. Complete investigations for deviations. CAPAs Responsible for opening CAPAs as needed. Ability to complete effectiveness checks. Ensure on-time closure of CAPAs and Effectiveness Checks for the MO organization. Ability to work cross-functionally to make necessary updates to documents. Change Controls Ability to complete change control actions within QMS as needed. Responsible for on-time closure of Change Controls Actions for the MO organization. Facilitate pre-CCRB meetings and attend CCRB. Ability to open Change Controls and associated actions. Continuous Improvement Human avoidable deviation reduction driven with continuous improvement. Required for all job functions Ability to collaborate with Manufacturing Operations, QA, MSAT, and other groups to verify the correct reviewers and approvers are selected. Ensuring on time completion for all actions of the MO organization. Other duties may be assigned, as necessary. Ability to project manage QMS records.

Specific Knowledge, Skills, Abilities: Must have knowledge of cGMP Manufacturing and/or Quality. Must be able to work independently and with critical thinking mindset. Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision. Builds relationships internally within and with cross functional teams. Contributes to goals within the work group. Able to recognize conflict and notify management with proposed recommendations for resolution. Able to prepare written communications and communicate problems to management with clarity and accuracy. Able to effectively multi-task. Excellent verbal and written communication skills. Knowledge of cGMP and FDA regulated industry. Strong technical and compliance writing capability. Proficient in MS Office applications. Education/Experience/ Licenses/Certifications: Bachelor’s degree with ability to learn Manufacturing Technical Writing skills. OR Associate/ Medical Technical degree and 1-2 years of Manufacturing or Operations experience. OR High School diploma/GED and 2 years of Manufacturing or Operations experience, with emphasis on Technical Writing and/or QA role.

On site presence is based on business need and will be communicated by management In