Bristol-Myers Squibb
Associate Technical Writer, Manufacturing Technical Support
Bristol-Myers Squibb, Summit, New Jersey, us, 07902
Associate Technical Writer, Manufacturing Technical Support
Working with Us
If your skills, experience, and qualifications match those in this job overview, do not delay your application.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, 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 will 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:DeviationsAttend 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.CAPAsResponsible 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 ControlsAbility 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 ImprovementHuman avoidable deviation reduction driven with continuous improvement.Required for all job functionsDemonstrated 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 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.Basic mathematical skills.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:Onsite 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. 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 the 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. Potential exposure to human blood components and strong magnets. Designated clean room areas will prohibit food, any outside materials such as cell phones, tablets, at a minimum.
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Working with Us
If your skills, experience, and qualifications match those in this job overview, do not delay your application.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, 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 will 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:DeviationsAttend 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.CAPAsResponsible 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 ControlsAbility 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 ImprovementHuman avoidable deviation reduction driven with continuous improvement.Required for all job functionsDemonstrated 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 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.Basic mathematical skills.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:Onsite 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. 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 the 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. Potential exposure to human blood components and strong magnets. Designated clean room areas will prohibit food, any outside materials such as cell phones, tablets, at a minimum.
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