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

Biopharma Careers; Summit West (CA); On-site; USD 99,315,000 - 120,347,000; Full time

Benefits offered by this job

Health coverage

Wellbeing programs

401(k) plan

Job summary

Bristol Myers Squibb is seeking a Manufacturing Quality Support professional to collaborate with MO, QA, MSAT, and other groups. The role focuses on deviations, CAPAs, and change controls while ensuring timely completion and cross-functional updates.

The candidate should have a strong understanding of cGMP, be able to work independently, multi-task, and communicate clearly in written form, with emphasis on quality documentation and regulatory compliance.

Qualifications

• Must have knowledge of cGMP Manufacturing and/or Quality.
• Requires independent work with critical thinking.

Responsibilities

• Attend alignment meetings and review deviations; ensure timelines are met.
• Open CAPAs and ensure on-time closure for MO.
• Complete change control actions within QMS and CCRB attendance.

Skills

cGMP knowledge

Independent work

Multi-tasking

Written communication

Problem solving

Education

Bachelor’s degree

Associate/Medical Tech degree

High School diploma/GED

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. Read more: careers.bms.com/working-with-us .

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. 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.

Compensation Overview

Summit West - NJ - US: $34.66 - $42.00per hour

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Work-life benefits include:

• Paid Time Off

US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)

Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

Uniquely Interesting Work, Life-changing Careers

With 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 a supportive culture, promoting global participation 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 Protocol

BMS has an 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.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.