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

Bristol Myers Squibb; Summit (NJ); On-site; USD 95,000 - 135,000; Full time

Job summary

Bristol Myers Squibb seeks an associate to collaborate with internal Manufacturing partners, such as MSAT, Warehouse, Environmental Health and Safety (EHS) and Quality, to support improvement actions (Deviations, CAPAs, Change Control and Document updates).

The associate will work with MO and Quality teams on CAPAs and Change Controls to ensure on-time implementation and maintain GMP documents for S12 CAR T manufacturing.

Qualifications

• Experience handling GMP deviations and CAPAs.
• Ability to review and update QMS documents.
• Cross-functional collaboration with MO, QA, MSAT to ensure on-time closures.

Responsibilities

• Attend alignment meetings and review deviations.
• Open and close CAPAs with effectiveness checks.
• Complete change control actions and ensure timely closures.

Skills

Deviations management

CAPAs

Change controls

Job description

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.

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.

Position 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.