Associate Technical Writer, 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 rich in diversity. 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.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Associate, Manufacturing Technical Services will collaborate with internal Manufacturing partners, such as but not limited to MS&T (Manufacturing Science & Technology), Warehouse, EHS and Quality groups to support the completion of improvement actions (No Impacts, CAPAs, Change Control Actions and Document updates).

Additionally, the Associate is to collect information from triage and initiate the record in the Quality Management System (QMS) with the applicable information.  The associate with support No Impact Deviations.

The Manufacturing Records and Procedures Associate will also be responsible for working with the MO and QA teams on CAPAs and Change Control Actions as needed and ensure on time implementation, effectiveness checks and closure of actions.  Associates will write, revise, and review all related GMP documentation for S12 CAR T manufacturing records and procedures including SOPs and Work Instructions.

Associates will review manufacturing batch records and any/all records used at the CAR T manufacturing and testing facilities.

Shifts Available:

• Monday - Friday, Onsite Day Shift, 9 a.m. - 5 p.m.

Responsibilities:

Deviations

• Attend alignment meetings, evaluate and provide feedback on severity classification.

• Able to handle no Impact deviations, which require rapid turnaround.

• Ability to create and/or review already created QMS deviations, provide feedback when needed, and ensure timelines are met.

CAPAs

• Responsible for opening CAPAs as needed to revise, SOPs, Work Instructions, to support new product/process implementation.

• Ability to complete CAPA Actions as needed within QMS.

• Ability to complete effectiveness checks that may require historical reviews or spot checks as needed.

• Responsible for on-time closure of CAPAs and Effectiveness Checks.

• Ability to work cross-functionally to make necessary updates to procedures/documents to address procedural gaps.

Change Controls

• Ability to complete change control actions within EQMS as needed.

• Ability to work cross-functionally to make necessary updates to procedures to address procedural gaps and/or new processes implementation.

• Responsible for on-time closure of Change Controls Actions.

Continuous Improvement

• Human avoidable deviation reduction driven with continuous improvement.

Required for all job functions

• Demonstrated ability to collaborate with Manufacturing Operations, QA, MS&T, and other groups to verify the correct reviewers/approvers are selected.

• Ensuring on time review/approval/effectiveness.

• Other duties may be assigned, as necessary.

Knowledge & Skills:

• Must have knowledge of cGMP manufacturing, Quality, FDA and compliance.

• Knowledge of US and global cGMP requirements.

• Must possess an independent mi