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

Bristol-Myers Squibb; United States; On-site; USD 70,000 - 95,000; Full time

Job summary

Bristol Myers Squibb is seeking a Manufacturing Technical Writer to support Deviations, CAPAs, and Change Controls. You will draft, revise, and review GMP documentation, ensuring on-time completion and accuracy while collaborating with Manufacturing Operations, QA, and MSAT teams.

Ideal candidates have strong written communication skills, the ability to multi-task, and experience with quality systems. On-site role with cross-functional interactions in a fast-paced environment.

Qualifications

• Must have knowledge of cGMP Manufacturing and/or Quality.
• Requires independent work with critical thinking mindset.
• Ability to project manage QMS records and collaborate cross-functionally.

Responsibilities

• Attend alignment meetings and review QMS deviations.
• Open CAPAs and ensure timely closure and effectiveness checks.
• Complete change control actions within QMS and coordinate with MO.
• Drive continuous improvement and reduce human avoidable deviations.
• Collaborate with MO, QA, MSAT and other groups to verify reviewers/approvers.

Skills

cgmp manufacturing knowledge

quality mindset

critical thinking

written communication

multitasking

Education

Bachelor's degree (Manufacturing/Technical Writing)

Associate/Medical Technical degree + 1–2 years experience

High School diploma + 2 years experience in Manufacturing/QA

Tools

MS Office

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.

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.

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.
• 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.

Qualifications

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.

Working Conditions:

On site presence is based on business need and will be communicated by management In our shared office space, designated seating arrangements are available for all Specialists. There will be sufficient lighting and temperature control regardless of season or time of day. Noise ideally is kept to a minimum in this shared environment to maximize our efficiency and communication skills. Heavy lifting and other strenuous activities are unnecessary and should not be performed unless otherwise stated by your manager. Sitting for long periods of time is required for this position, however, at times employees may be obligated to walk to other departments for several reasons. It is recommended, but not required, to get up every hour or so for a short walk as defined in ergonomics training. Although position is primarily office based, some on floor/clean room interactions may be required. Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals and exposure to sanitization agents could be expected. Potenti