Specialist, Senior Technical Writer, Mts

Working with UsChallenging. 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.Cell Therapyis one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS's continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.TheSpecialist, Senior Technical Writerwill collaborate with internal Manufacturing partners, such as but not limited to MS&T (Manufacturing Science & Technology), Warehouse, EHS and Quality groups to drive completion of improvement actions (Investigations, CAPAs, Change Controls and Document updates).Additionally, the Senior Associate is to collect information from triage and initiate the record in the Quality Management System (QMS) with the applicable information. The Senior Associate will lead Manufacturing No ImpactDeviations.The Senior Associate will support the Manufacturing Records and Procedures Manager and Lead Associate in working with the MO and QA teams to agree on appropriate CAPAs as needed for on time implementation, effectiveness checks and closure of actions. The Senior Associate will write, revise, and review all related GMP documentation to support S12 CAR T manufacturing operations including SOPs and Work Instructions.The Senior Associate shall review manufacturing batch records and any/all records used at the CAR T manufacturing and testing facilities.Shifts Available:TBD Responsibilities:DeviationsAttend alignment meetings for alignment on event and severity.Able to handle completion of Deviation Assessment phase.Rapid turnaround for initiation of deviations. Collect information from triage and initiate the record in the Quality Management System (QMS). Determine the scope of the problem and determine severity.Lead Manufacturing No Impact Events to ensure on time closure.Support RCA investigations as needed.CAPAsAble to support the Manufacturing Records and Procedure Manager and Lead in collaborative efforts with cross-functional departments to build and leverage ideas, data, and insights for CAPAs, effectiveness checks and document updates.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 due to procedural gaps.Change ControlsAble to support the Manufacturing Records and Procedure Manager and Lead in collaborative efforts with cross-functional departments to build and leverage ideas, data, and insights for change controls, effectiveness checks and document updates.Ability to complete change control actions within QMS 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 and applicable Effectiveness Checks.Continuous ImprovementAbility to support continuous improvement initiatives.Able to be a critical thinker to develop and optimize work processes.Manufacturing Operations Batch Record Review (MOBRR)Must have knowledge and experience in cGMP Manufacturing, Compliance or Quality.Time (RFT) to avoid missed corrections.Performs other assigned duties as may be required to meet company objectives.Communicates effectively with other departments within the organization and functions well within a team environment.Attends triage calls/meetings if needed.Able to support Minor, Major, and Criticaldeviations/investigations.Possesses strong attention to detail.Possesses good written and oral communication skills.Proficient in MS Outlook, Word, and Excel.Possesses strong interpersonal skills and the ability to work well in a team environment.Possesses good time management skills and can coordinate multiple tasks efficiently.Required for all job functionsDemonstrated ability to collaborate with Manufacturing Operations, QA, MS&T, and other groups to appropriately assign deviation investigations, CAPAs, Change Controls and support closure, if needed.Consistently Right first time when moving documents through our document management system.Verify the correct reviewers/approvers are selected.Pushing on timereview/approval/effectiveness.Other duties may be assigned, as necessary.Knowledge & Skills:Understanding of cell culture, cryopreservation, and aseptic processing for cell therapy drug products.Must have knowledge and experience with cGMP manufacturing, Quality, FDA and compliance.Knowledge of US and global cGMP requirements.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.Some knowledge in leading and closing Root Cause Analysis to support lot release.Some knowledge with CAPAs and Change Controls.Must possess an independent mindset.Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.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.Basic Requirements:Bachelor's degree plus 1-2 years of experience in Manufacturing Technical Writing or in a QA roleOR Associate/ Medical Technical degree and 2-4 years of Manufacturing or Operations experienceOR High School diploma/GED and 5 years of Manufacturing or Operations experience, with emphasis on Technical Writing and/or QA role.Working Conditions:Employees are required to be available every day on site unless stated by your manager. 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 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.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.If you want to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.BMSCART#LI-ONSITEIf you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as "Transforming patients' lives through science™ ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries ******. Visitcareers.bms.com/eeo-accessibilityto access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.