Bristol Myers Squibb · 1 day ago
Document Control Specialist
Indianapolis, IN
Full-time
Onsite
Mid Level
$34.05/hr - $41.26/hr
3+ years expBristol Myers Squibb is a dynamic biotechnology company focused on improving survival rates for cancer patients through innovative treatments. The Document Control Specialist will oversee the document control system at a new Radiopharmaceutical facility, ensuring compliance and quality assurance for clinical development and GMP operations.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Manage the process for the creation, review, approval, and issuance of GxP controlled site documents and records including batch records, logbooks, forms, procedures, protocols, templates, and reports
Manage electronic document management system (EDMS) document lifecycle workflows and assignment of reviewers / approvers and training tasks
Review the format and metadata of new documents to ensure compliance with approved templates, procedures and EDMS requirements
Provide guidance to document initiators, owners, and users to ensure compliance with all applicable procedures / regulations and assist users with EDMS workflow related issues
Manage the periodic review of controlled documents and partner with document owners to ensure periodic reviews are completed within the required timelines
Coordinate and liaise with other departments to facilitate uniform quality standards for the site
Ensure that compliance to the training program is maintained and updated as needed
Process DCR packages and review for correctness and completeness; monitor and update in-process documents
Create, assign, and archive QA controlled lab notebooks and logbooks
Qualification
Required
3-5 years of quality assurance experience
Working knowledge of 21 CFR Parts 11, 210, and 211
Highly motivated and organized professional with the ability to work independently
Very personable with strong communication skills
Excellent professional ethics, integrity, and ability to maintain confidential information
Preferred
BS/MS in a Science related discipline
Pharmaceutical and GMP experience
Experience working with FDA or other federal and state regulatory bodies
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
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.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2026-01-09
2026-01-08
Company data provided by crunchbase