Deviation Investigator

Bristol Myers Squibb • Indianapolis, IN

1d • $34 - $41 • 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.
• 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.

Nice To Haves

• 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.
• 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

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level