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

Bristol Myers Squibb • Summit, NJ

7d • $35 - $42 • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• Ability to learn Manufacturing Technical Writing skills.

Responsibilities

• 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.
• 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.
• 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.
• Human avoidable deviation reduction driven with continuous improvement.
• 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.
• Ability to project manage QMS records.

Benefits

• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree