Deviation Investigator

Bristol Myers Squibb•Indianapolis, IN

4d•Onsite

About The Position

The Deviation Investigator leads compliant manufacturing deviation investigations in a GMP radiopharmaceutical environment. The role partners with cross-functional teams to assess product quality impact, determine root cause, define CAPAs, and support timely product release and quality commitments.

Requirements

Bachelor’s or master’s degree in a scientific, engineering, pharmaceutical, biotechnology, or related field; equivalent experience may be considered.
2–7 years of experience in GMP manufacturing, quality, validation, MS&T, technical operations, or a related regulated environment.
Experience in radiopharmaceutical, sterile injectable, aseptic, biologic, pharmaceutical, or similar regulated manufacturing preferred.
Experience with deviation investigations, root cause analysis, CAPA development, GMP documentation, and inspection readiness preferred.
Strong technical writing skills and ability to produce clear, audit-ready GMP documentation.
Working knowledge of cGMP, quality systems, deviation management, CAPA, change control, and data integrity expectations.
Strong analytical, organizational, interpersonal, facilitation, and communication skills.
Ability to manage multiple priorities and drive investigations to closure in a fast-paced environment.
High degree of ownership, independence, accountability, sound judgment, ethics, and confidentiality.
Proficiency with electronic quality systems, document management systems, Microsoft Office, and data review tools preferred.

Responsibilities

Lead, document, and close manufacturing deviation investigations in alignment with GMP requirements and internal procedures.
Apply root cause analysis tools and risk-based decision-making to assess scope, recurrence, and product quality impact.
Review batch records, equipment records, electronic data, logbooks, environmental monitoring, analytical data, and other supporting documentation.
Partner with Manufacturing, Quality, Engineering, Validation, MS&T, and other SMEs to gather evidence and develop scientifically justified conclusions.
Develop and manage CAPAs, including effectiveness criteria, due dates, and timely closure.
Draft and revise GMP documentation, including deviations, CAPAs, SOPs, forms, change controls, reports, and supporting records.
Monitor trends, KPIs, and recurring issues to support continuous improvement, inspection readiness, and quality system performance.
Support internal audits, health authority inspections, product release timelines, and other site business needs as assigned.

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
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.
Flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) for US Exempt Employees.
160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays for Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees.
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.
Annual Global Shutdown between Christmas and New Years Day.