Sr. Specialist - QA Document Control

Bristol Myers Squibb • Indianapolis, IN

1d • $82,236 - $99,650 • Onsite

About The Position

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/ Summary The Senior Document Control Specialist independently executes and oversees GxP document control and records management activities supporting RayzeBio’s Indianapolis operations. This role functions as a senior individual contributor and subject matter expert (SME) within the Document Control program, applying established quality system frameworks to resolve non‑routine documentation and records issues. The Senior Document Control Specialist provides guidance to document authors and functional stakeholders, supports regulatory inspections, and supports regulatory inspections and contributes to site-level continuous improvement initiatives without direct people management or global program ownership.

Requirements

• BS/MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred
• Minimum 4+ years of direct document control or quality systems experience in a regulated GxP environment (pharmaceutical, biotech, or radiopharmaceutical preferred).
• Detail-oriented with demonstrated applications in problem solving and decision-making abilities with moderate oversight from management
• Team player who can work independently to achieve objectives in a fast-paced environment
• Excellent verbal and written communication skills.
• Well-practiced in exercising sound judgment in decision-making.
• Demonstrated prioritization and organization skills.

Nice To Haves

• Experience working with FDA or other regulatory authorities is preferred.
• Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired.
• Knowledge and proven experience in FDA, EMA, or other regulatory authority.

Responsibilities

• Execute full lifecycle management of controlled GxP documents.
• Review formatting, metadata, and GDP compliance.
• Issue, reconcile, and archive controlled documents.
• Manage eDMS workflows and provide troubleshooting.
• Support audits through organized document retrieval.
• Support change-related documentation (deviations, CAPAs, change controls).
• Train employees in document control procedures.
• Mentor junior specialists.
• Generate metrics and support process improvements.
• Coordinates with internal and external stakeholders to troubleshoot issues when required.
• Identify and report discrepancies from required work practices or procedures to management.
• Make sound decisions by exercising judgment within generally defined practices and policies and apply appropriate notification to management as appropriate.
• Participate as requested in the response team for audits and inspections by health authorities.

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. 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: Mid Level