Associate Technical Writer, MTS CAR-T Manufacturing in Summit, NJ

Associate Technical Writer, MTS CAR-T Manufacturing in Summit, NJ

Working with Us

If you are interested in applying for this job, please make sure you meet the following requirements as listed below.

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.

The Associate Technical Writer, MTS CAR-T Manufacturing will collaborate with internal Manufacturing partners, such as but not limited to MS&T (Manufacturing Science & Technology), Warehouse, EHS (Environmental Health and Safety) and Quality groups to support the completion of improvement actions (No Impacts, Minors, 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 Technical Writer, MTS CAR-T Manufacturing 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 documents.

Shifts Available :

Monday Friday, Standard Working Hours

Responsibilities : Deviations

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.
• Complete investigations for minor deviations.

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 and 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.
• Understanding of cell culture, cryopreservation, and aseptic processing for cell therapy drug products.
• Knowledge of cGMP / FDA regulated industry.
• Strong technical and compliance writing capability.
• Proficient in MS Office applications.
• Background to include an understanding of biology, chemistry, medical or clinical practices.

Basic Requirements :

• 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 your efficiency and communication skills.

Although position is primarily office based, some on floor / clean room interactions may be required.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.

The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.

There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.

Employees holding this position will be required to perform any other job-related duties as requested by management.

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